Supplemental Evidence and Data Request on Diagnosis and Management of Obsessive Compulsive Disorders in Children, 58581-58584 [2023-18415]
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Federal Register / Vol. 88, No. 165 / Monday, August 28, 2023 / Notices
GSA Bulletin FTR 23–07 can be
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Krystal J. Brumfield,
Associate Administrator, Office of
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[FR Doc. 2023–18398 Filed 8–25–23; 8:45 am]
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SUMMARY:
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58581
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: 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 Diagnosis and Management
of Obsessive Compulsive Disorders in
Children. AHRQ is conducting this
review pursuant to Section 902 of the
Public Health Service Act, 42 U.S.C.
Approved: August 23, 2023.
299a.
Shelley K. Finlayson,
The EPC Program is dedicated to
Acting Director, U.S. Office of Government
identifying as many studies as possible
Ethics.
that are relevant to the questions for
[FR Doc. 2023–18526 Filed 8–25–23; 8:45 am]
each of its reviews. In order to do so, we
BILLING CODE 6345–03–P
are supplementing the usual manual
and electronic database searches of the
literature by requesting information
DEPARTMENT OF HEALTH AND
from the public (e.g., details of studies
HUMAN SERVICES
conducted). We are looking for studies
that report on Diagnosis and
Agency for Healthcare Research and
Management of Obsessive Compulsive
Quality
Disorders in Children. The entire
research protocol is available online at:
Supplemental Evidence and Data
https://effectivehealthcare.ahrq.gov/
Request on Diagnosis and
products/obsessive-compulsiveManagement of Obsessive Compulsive
disorder/protocol.
Disorders in Children
This is to notify the public that the
AGENCY: Agency for Healthcare Research EPC Program would find the following
information on Diagnosis and
and Quality (AHRQ), HHS.
Management of Obsessive Compulsive
ACTION: Request for supplemental
Disorders in Children helpful:
evidence and data submissions.
D A list of completed studies that
SUMMARY: The Agency for Healthcare
your organization has sponsored for this
Research and Quality (AHRQ) is seeking topic. In the list, please indicate
scientific information submissions from whether results are available on
the public. Scientific information is
ClinicalTrials.gov along with the
being solicited to inform our review on
ClinicalTrials.gov trial number.
Diagnosis and Management of Obsessive
D For completed studies that do not
Compulsive Disorders in Children,
have results on ClinicalTrials.gov, a
which is currently being conducted by
summary, including the following
the AHRQ’s Evidence-based Practice
elements, if relevant: study number,
Centers (EPC) Program. Access to
study period, design, methodology,
published and unpublished pertinent
indication and diagnosis, proper use
scientific information will improve the
instructions, inclusion and exclusion
quality of this review.
criteria, primary and secondary
outcomes, baseline characteristics,
DATES: Submission Deadline on or
number of patients screened/eligible/
before September 27, 2023.
enrolled/lost to follow-up/withdrawn/
ADDRESSES:
analyzed, effectiveness/efficacy, and
Email submissions: epc@
safety results.
ahrq.hhs.gov.
D A list of ongoing studies that your
Print submissions:
organization has sponsored for this
Mailing Address: Center for Evidence
topic. In the list, please provide the
and Practice Improvement, Agency for
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Federal Register / Vol. 88, No. 165 / Monday, August 28, 2023 / Notices
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
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 45 days.
If you would like to be notified when
the draft is posted, please sign up for the
email list at: https://www.effective
healthcare.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: How accurate are assessment
tools compared to reference standard
methods to identify OCD in
symptomatic children and adolescents?
KQ 1a: How does diagnostic accuracy
of assessment tools vary by patient,
family, social, or other characteristics,
or by respondent type?
KQ 2: What are the comparative
effects and harms of treatment
interventions, used alone or in
combination, for OCD in children and
adolescents?
KQ 2a: How do the effectiveness and
harms vary with patient, family, social,
or other characteristics?
Study Eligibility Criteria
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)
Key Question 1
(diagnosis of OCD)
Population ..................................
Interventions ..............................
Key Question 2
(treatment of OCD)
Children and adolescents (<21 years):
• in whom there is clinical consideration of OCD.
• diagnosed with OCD and/or other conditions which may be either be comorbid with OCD or may present with similar symptoms.
Include:
• Studies evaluating only children and adolescents with OCD
(to estimate test sensitivity alone).
Exclude:
• Studies that include both adults and children that do not explicitly report a pediatric or adolescent subgroup in the abstract.
• Studies that perform population-based screening (among individuals without a clinical concern for OCD).
Index Test(s):
• Tools to diagnose OCD in symptomatic patients. For example,
Æ Obsessive Compulsive Inventory-Child Version (OCI–
CV–R).
Æ Toronto Obsessive-Compulsive Scale (TOCS).
Æ Short Obsessive-Compulsive Screener (SOCS).
• Diagnostic prediction models.
• Must report use of specific cut-point(s) to classify an individual as having OCD or a prediction algorithm or model to
predict the probability of OCD.
• Alternative administration (e.g., child versus parent versus
teacher report, in-person versus telehealth).
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Exclude:
• Specific individual symptoms, behaviors, or characteristics.
• Genetic studies.
• Biomarker studies.
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Children and adolescents (<21 years) with diagnosed OCD, including those with:
• possible PANS/PANDAS (with OCD).
• other comorbid conditions (e.g., autism).
Exclude:
• Children and adolescents diagnosed with other OCD-spectrum conditions (e.g., body dysmorphic disorder, body focused
repetitive behaviors) without an OCD diagnosis.
• Subclinical OCD or obsessive or compulsive symptoms without an OCD diagnosis.
• Studies that include both adults and children that do not explicitly report a subgroup by age in the abstract.
Psychological interventions for OCD, alone or in combination
with pharmacological and/or other interventions, including:
• Cognitive behavioral therapy (CBT).
Æ Exposure and response prevention (ERP).
Æ Psychoeducation.
Æ Coping skills.
Æ Cognitive therapy.
• Acceptance and commitment therapy (ACT).
• Targeted family interventions.
• Other psychological interventions.
• Delivery method.
Æ Therapist led, e.g., scheduled, in-person, or via telephone, video conference.
Æ Self-guided, e.g., asynchronous, therapist serves as supportive coach.
Pharmacological interventions, alone or in combination with psychological interventions:
• Selective serotonin reuptake inhibitors (SSRIs).
• Tricyclic antidepressants (TCA), including clomipramine.
• Serotonin and norepinephrine reuptake inhibitors (SNRIs).
• Medication augmentation strategies:
Æ SSRI augmentation with clomipramine, and other medications, including neuroleptics, nonsteroidal anti-inflammatory drugs (NSAIDs).
Æ Glutamate modulating agents (e.g., D-cycloserine,
riluzole).
• Other pharmacologic interventions, alone or in combination
with psychological and/or other interventions, including dose
escalation, longer treatment duration.
Neuromodulation interventions:
• Transcranial magnetic stimulation (TMS),
• Transcranial direct current stimulation (tDCS),
• Transcranial alternating current stimulation (tACS),
• Deep brain stimulation (DBS).
Complementary/integrative therapies:
• Naturopathic interventions.
• Mind-body practices (e.g., mindfulness, meditation, yoga).
• Sensory integration (e.g., deep pressure).
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58583
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)—Continued
Key Question 1
(diagnosis of OCD)
Comparators ..............................
Outcomes (prioritized outcomes
have an asterisk and are in
bold font).
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Potential Effect Modifiers/Subgroups of interest.
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Key Question 2
(treatment of OCD)
Reference standard(s):
• Clinical interview.
• Validated diagnostic assessment instruments (others may be
included).
Æ Anxiety Disorders Interview Schedule for DSM–5 child
version.
Æ (ADIS–C).
Æ Kiddie Schedule for Affective Disorders and Schizophrenia, Present and Lifetime version (K–SADS–PL) for
DSM–5.
Æ Mini-International Neuropsychiatric Interview for Children
and Adolescents (MINI–KID).
Æ Children’s Yale-Brown Obsessive-Compulsive Scale
(CY–BOCS).
Æ Children’s Yale-Brown Obsessive-Compulsive Scale Second Edition (CY–BOCS–II).
• Different index tests (if also compared with reference standard).
• Different reference standards (i.e., comparison of reference
standards).
• Different respondents (e.g., clinician, self, parent, educator).
• Different methods to give test (e.g., in person vs. via telehealth).
• Different populations (see effect modifiers below).
OCD diagnosis:
• Sensitivity/Specificity.*
• Positive and negative likelihood ratios.
• Accuracy.
• Area under the Receiver Operator Characteristic Curve (AUC
ROC).
• Predicted probability of OCD (model calibration/discrimination).
• Time to initiation of treatment (cohort studies).
Exclude:
• Studies not reporting predictive validity that report other psychometric properties of scales: for example, reliability or validity (content, construct, convergent, discriminant, divergent,
face).
• Patient, family, social, and other characteristics, including:
Æ Race/Ethnicity (racial and ethnic discrimination is the effect modifier of interest but many/most studies will not
contain that so we will use race/ethnicity as a marker for
likelihood of experience with discrimination and would explicitly discuss this in the review).
Æ Identity and Culture (e.g., spiritual and religious beliefs
and practices, native language, gender identity, sexual
orientation, physical/mental disability status)
Æ Age.
Æ Age at symptom onset.
Æ Social determinants of health, including education level,
socioeconomic status, immigration status, refugee status,
and geography (e.g., urban vs. rural).
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Exclude:
• Specific treatments for PANS/PANDAS (e.g., antibiotics,
immunomodulation, intravenous immunoglobulin).
• No treatment (e.g., waitlist control).
• Pill placebo or sham control.
• Another active intervention or co-intervention (e.g., relaxation
therapy).
• Alternative delivery methods.
OCD symptom severity:
• Children’s Yale-Brown Obsessive Compulsive Scale Total
(CY–BOCS).*
• Clinical Global Impression–Severity (CGI–S).*
Treatment response and remission:
• Clinical remission (posttreatment CY–BOCS total score ≤12
as defined by Farhat et. al.23, or as reported).*
• Clinical Global Impression–Improvement (CGI–I).*
Functional impairment in school, social, and home/family domains:
• The Child Obsessive Compulsive Impact Scale—Revised
(COIS–R).*
Æ Raters: child (COIS–C), parent (COIS–P).
Family accommodation:
• Family Accommodation Scale (FAS).*
Family functioning:
• OCD Family Functioning Scale.
• Family Environment Scale (FES).
• Parental Attitudes and Behaviors Scale (PABS).
Patient/parent reported experience measures (PREMs).
Patient reported outcome measure (PROMs):
• Top Problems assessment (TPA).
Quality of Life (QoL) General and Health Related (HRQoL) (validated scales only): *
• Quality of Life Enjoyment and Satisfaction QuestionnaireShort Form (QLESQ).
Acceptability of treatment: *
• Parental satisfaction with services.
• Withdrawals/discontinuation.
Sleep-related problems.
Suicidal thoughts and behavior:
• Columbia Suicide Severity Rating Scale Recent Self-Report
Screener (C–SSRS).
Anxiety and depression.
Adverse events related to treatment.*
Exclude:
• Neuroimaging (e.g., functional MRI).
• Patient, family, social, and other characteristics, including:
Æ Race/Ethnicity (racial and ethnic discrimination is the effect modifier of interest but many/most studies will not
contain that so we will use race/ethnicity as a marker for
likelihood of experience with discrimination and would explicitly discuss this in the review).
Æ Identity and Culture (e.g., spiritual and religious beliefs
and practices, native language, gender identity, sexual
orientation, physical/mental disability status).
Æ Age.
Æ Age at symptom onset.
Æ Social determinants of health, including education level,
socioeconomic status, immigration status, refugee status,
and geography (e.g., urban vs. rural).
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Federal Register / Vol. 88, No. 165 / Monday, August 28, 2023 / Notices
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)—Continued
Key Question 1
(diagnosis of OCD)
Key Question 2
(treatment of OCD)
Æ
Æ
Æ
Æ
Diagnosis of PANS/PANDAS.
OCD in first degree relatives.
Level of family accommodation.
Co-occurring disorders (e.g., major depressive disorder,
anxiety disorders, attention-deficit hyperactivity disorder,
conduct disorders, autism spectrum disorder, and
Tourette syndrome, other tic disorders).
Æ Diagnosis during COVID–19 pandemic (as defined by
study authors).
Æ Primary versus specialist care.
• Respondent type.
Exclude:
• Neuroimaging, e.g., functional MRI.
Design ........................................
Timing ........................................
Setting ........................................
Cohort or cross-sectional studies:
• comparing an index test(s) to a reference standard.
• comparing an index test(s) in two or more subgroups of interest.
• comparing two or more diagnostic strategies.
Randomized controlled trials.
Nonrandomized comparative studies:
• prospective or retrospective with appropriate adjustment for
confounding.
Systematic reviews (for reference lists only).
Exclude:
• Prevalence studies.
• Qualitative studies.
• Case reports and case series.
• Unpublished studies, including conference abstracts (but include studies with reported results in the ClinicalTrials.gov
database).
Any.
Any, including administration of test(s) in-person or via telehealth.
Æ
Æ
Æ
Æ
Diagnosis of PANS/PANDAS.
OCD in first degree relatives.
Level of family accommodation.
Co-occurring disorders (e.g., major depressive disorder,
anxiety disorders, attention-deficit hyperactivity disorder,
conduct disorders, autism spectrum disorder, and
Tourette syndrome, other tic disorders).
Æ Diagnosis during COVID–19 pandemic (as defined by
study authors).
Æ Duration of symptoms prior to treatment.
Æ Symptom severity.
Æ In-session exposure and response prevention.
Æ Medication dose.
Æ Care settings and care intensities.
D Traditional outpatient.
D Intensive outpatient.
• Day programs (e.g., partial hospitalization).
• Residential.
D Inpatient.
D Other care settings, including school-based settings.
D Telehealth (vs. in-person).
D Primary versus specialist care.
Comparative trials:
• Randomized controlled trials.
• Nonrandomized comparative studies.
Æ prospective or retrospective with appropriate adjustment
for confounding.
Single arm studies, N ≥ 50:
• with multivariable analyses of potential effect modifiers/subgroups of interest.
Systematic reviews (for reference lists only).
Exclude:
• Cross-sectional studies (no longitudinal follow-up).
• Qualitative studies.
• Case reports and case series.
• Unpublished studies, including conference abstracts (but include studies with reported results in the ClinicalTrials.gov
database).
Any.
Any.
* Prioritized outcome.
Dated: August 21, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023–18415 Filed 8–25–23; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Clinical Laboratory Improvement
Advisory Committee
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
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AGENCY:
In accordance with regulatory
provisions, the Centers for Disease
Control and Prevention (CDC)
announces the following meeting of the
Clinical Laboratory Improvement
Advisory Committee (CLIAC). This is a
hybrid meeting, accessible both in
SUMMARY:
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person and virtually. It is open to the
public, limited only by the in-person
space available. The public is also
welcome to view the meeting by joining
the audio conference (information
below). Time will be available for public
comment, and the public is also
welcome to submit written comments in
advance of the meeting (see the public
participation section below).
DATES: The meeting will be held on
November 8, 2023, from 8:30 a.m. to
5:30 p.m., EST, and November 9, 2023,
from 8:30 a.m. to 12 p.m., EST.
ADDRESSES: Centers for Disease Control
and Prevention, 2400 Century Parkway
NE, Room 1020/1023, Atlanta, Georgia
30345. The conference room will have
seating for approximately 60 people.
Meeting Information: All people
attending the CLIAC meeting in person
are required to register online for the
meeting at least five business days in
advance for U.S. citizens and at least 20
business days in advance for
international registrants. Register at:
https://www.cdc.gov/cliac/upcoming-
PO 00000
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meeting.html. Register by scrolling
down and clicking the ‘‘Register for this
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given. Please complete all the required
fields before submitting your
registration and submit no later than
November 1, 2023, for U.S. registrants
and October 11, 2023, for international
registrants. The confirmed meeting
times, agenda items, and meeting
materials, including instructions for
accessing the live meeting broadcast,
will be available on the CLIAC website
at https://www.cdc.gov/cliac/upcomingmeeting.html.
FOR FURTHER INFORMATION CONTACT:
Heather Stang, MS, Senior Advisor for
Clinical Laboratories, Division of
Laboratory Systems, Office of
Laboratory Science and Safety, Centers
for Disease Control and Prevention,
1600 Clifton Road NE, Mailstop V24–3,
Atlanta, Georgia 30329–4027.
Telephone: (404) 498–2769; Email:
HStang@cdc.gov.
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 88, Number 165 (Monday, August 28, 2023)]
[Notices]
[Pages 58581-58584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-18415]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Diagnosis and
Management of Obsessive Compulsive Disorders in Children
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 Diagnosis and
Management of Obsessive Compulsive Disorders in Children, 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 September 27, 2023.
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 Diagnosis and
Management of Obsessive Compulsive Disorders in Children. 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 Diagnosis and Management of Obsessive Compulsive
Disorders in Children. The entire research protocol is available online
at: https://effectivehealthcare.ahrq.gov/products/obsessive-compulsive-disorder/protocol.
This is to notify the public that the EPC Program would find the
following information on Diagnosis and Management of Obsessive
Compulsive Disorders in Children 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
[[Page 58582]]
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 45 days.
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)
KQ 1: How accurate are assessment tools compared to reference
standard methods to identify OCD in symptomatic children and
adolescents?
KQ 1a: How does diagnostic accuracy of assessment tools vary by
patient, family, social, or other characteristics, or by respondent
type?
KQ 2: What are the comparative effects and harms of treatment
interventions, used alone or in combination, for OCD in children and
adolescents?
KQ 2a: How do the effectiveness and harms vary with patient,
family, social, or other characteristics?
Study Eligibility Criteria
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and Setting)
----------------------------------------------------------------------------------------------------------------
Key Question 1 (diagnosis of OCD) Key Question 2 (treatment of OCD)
----------------------------------------------------------------------------------------------------------------
Population....................... Children and adolescents (<21 years): Children and adolescents (<21 years)
in whom there is clinical with diagnosed OCD, including those
consideration of OCD. with:
diagnosed with OCD and/or possible PANS/PANDAS (with
other conditions which may be either OCD).
be comorbid with OCD or may present other comorbid conditions
with similar symptoms. (e.g., autism).
Include: Exclude:
Studies evaluating only Children and adolescents
children and adolescents with OCD (to diagnosed with other OCD-spectrum
estimate test sensitivity alone). conditions (e.g., body dysmorphic
disorder, body focused repetitive
behaviors) without an OCD diagnosis.
Exclude: Subclinical OCD or obsessive
Studies that include both or compulsive symptoms without an
adults and children that do not OCD diagnosis.
explicitly report a pediatric or Studies that include both
adolescent subgroup in the abstract. adults and children that do not
Studies that perform explicitly report a subgroup by age
population-based screening (among in the abstract.
individuals without a clinical
concern for OCD).
Interventions.................... Index Test(s): Psychological interventions for OCD,
Tools to diagnose OCD in alone or in combination with
symptomatic patients. For example, pharmacological and/or other
interventions, including:
[cir] Obsessive Compulsive Cognitive behavioral therapy
Inventory-Child Version (OCI-CV- (CBT).
R). [cir] Exposure and response
[cir] Toronto Obsessive-Compulsive prevention (ERP).
Scale (TOCS). [cir] Psychoeducation.
[cir] Short Obsessive-Compulsive [cir] Coping skills.
Screener (SOCS). [cir] Cognitive therapy.
Diagnostic prediction models. Acceptance and commitment
Must report use of specific therapy (ACT).
cut-point(s) to classify an Targeted family
individual as having OCD or a interventions.
prediction algorithm or model to Other psychological
predict the probability of OCD. interventions.
Alternative administration Delivery method.
(e.g., child versus parent versus [cir] Therapist led, e.g., scheduled,
teacher report, in-person versus in-person, or via telephone, video
telehealth). conference.
[cir] Self-guided, e.g.,
asynchronous, therapist serves as
supportive coach.
Exclude:
Specific individual symptoms, Pharmacological interventions, alone
behaviors, or characteristics. or in combination with psychological
Genetic studies. interventions:
Biomarker studies. Selective serotonin reuptake
inhibitors (SSRIs).
Tricyclic antidepressants
(TCA), including clomipramine.
...................................... Serotonin and norepinephrine
reuptake inhibitors (SNRIs).
...................................... Medication augmentation
strategies:
...................................... [cir] SSRI augmentation with
clomipramine, and other
medications, including
neuroleptics, nonsteroidal anti-
inflammatory drugs (NSAIDs).
...................................... [cir] Glutamate modulating agents
(e.g., D-cycloserine, riluzole).
...................................... Other pharmacologic
interventions, alone or in
combination with psychological and/
or other interventions, including
dose escalation, longer treatment
duration.
...................................... Neuromodulation interventions:
...................................... Transcranial magnetic
stimulation (TMS),
...................................... Transcranial direct current
stimulation (tDCS),
...................................... Transcranial alternating
current stimulation (tACS),
...................................... Deep brain stimulation
(DBS).
...................................... Complementary/integrative therapies:
...................................... Naturopathic interventions.
...................................... Mind-body practices (e.g.,
mindfulness, meditation, yoga).
...................................... Sensory integration (e.g.,
deep pressure).
[[Page 58583]]
...................................... Exclude:
...................................... Specific treatments for PANS/
PANDAS (e.g., antibiotics,
immunomodulation, intravenous
immunoglobulin).
Comparators...................... Reference standard(s): No treatment (e.g., waitlist
control).
Clinical interview. Pill placebo or sham
control.
Validated diagnostic Another active intervention
assessment instruments (others may be or co-intervention (e.g., relaxation
included). therapy).
[cir] Anxiety Disorders Interview Alternative delivery
Schedule for DSM-5 child version. methods.
[cir] (ADIS-C).
[cir] Kiddie Schedule for Affective
Disorders and Schizophrenia,
Present and Lifetime version (K-
SADS-PL) for DSM-5.
[cir] Mini-International
Neuropsychiatric Interview for
Children and Adolescents (MINI-
KID).
[cir] Children's Yale-Brown
Obsessive-Compulsive Scale (CY-
BOCS).
[cir] Children's Yale-Brown
Obsessive-Compulsive Scale Second
Edition (CY-BOCS-II).
Different index tests (if
also compared with reference
standard).
Different reference standards
(i.e., comparison of reference
standards).
Different respondents (e.g.,
clinician, self, parent, educator).
Different methods to give
test (e.g., in person vs. via tele-
health).
Different populations (see
effect modifiers below).
Outcomes (prioritized outcomes OCD diagnosis: OCD symptom severity:
have an asterisk and are in bold Sensitivity/Specificity.* Children's Yale-Brown
font). Positive and negative Obsessive Compulsive Scale Total (CY-
likelihood ratios. BOCS).*
Accuracy. Clinical Global Impression-
Area under the Receiver Severity (CGI-S).*
Operator Characteristic Curve (AUC Treatment response and remission:
ROC). Clinical remission
Predicted probability of OCD (posttreatment CY-BOCS total score
(model calibration/discrimination). <=12 as defined by Farhat et. al.23,
Time to initiation of or as reported).*
treatment (cohort studies). Clinical Global Impression-
Improvement (CGI-I).*
Exclude:
Studies not reporting Functional impairment in school,
predictive validity that report other social, and home/family domains:
psychometric properties of scales: The Child Obsessive
for example, reliability or validity Compulsive Impact Scale--Revised
(content, construct, convergent, (COIS-R).*
discriminant, divergent, face). [cir] Raters: child (COIS-C), parent
(COIS-P).
...................................... Family accommodation:
...................................... Family Accommodation Scale
(FAS).*
...................................... Family functioning:
...................................... OCD Family Functioning
Scale.
...................................... Family Environment Scale
(FES).
...................................... Parental Attitudes and
Behaviors Scale (PABS).
...................................... Patient/parent reported experience
measures (PREMs).
...................................... Patient reported outcome measure
(PROMs):
...................................... Top Problems assessment
(TPA).
...................................... Quality of Life (QoL) General and
Health Related (HRQoL) (validated
scales only): *
...................................... Quality of Life Enjoyment
and Satisfaction Questionnaire-Short
Form (QLESQ).
...................................... Acceptability of treatment: *
...................................... Parental satisfaction with
services.
...................................... Withdrawals/discontinuation.
...................................... Sleep-related problems.
...................................... Suicidal thoughts and behavior:
...................................... Columbia Suicide Severity
Rating Scale Recent Self-Report
Screener (C-SSRS).
...................................... Anxiety and depression.
...................................... Adverse events related to treatment.*
...................................... Exclude:
...................................... Neuroimaging (e.g.,
functional MRI).
Potential Effect Modifiers/ Patient, family, social, and Patient, family, social, and
Subgroups of interest. other characteristics, including: other characteristics, including:
[cir] Race/Ethnicity (racial and [cir] Race/Ethnicity (racial and
ethnic discrimination is the effect ethnic discrimination is the effect
modifier of interest but many/most modifier of interest but many/most
studies will not contain that so we studies will not contain that so we
will use race/ethnicity as a marker will use race/ethnicity as a marker
for likelihood of experience with for likelihood of experience with
discrimination and would explicitly discrimination and would explicitly
discuss this in the review). discuss this in the review).
[cir] Identity and Culture (e.g., [cir] Identity and Culture (e.g.,
spiritual and religious beliefs spiritual and religious beliefs
and practices, native language, and practices, native language,
gender identity, sexual gender identity, sexual
orientation, physical/mental orientation, physical/mental
disability status) disability status).
[cir] Age. [cir] Age.
[cir] Age at symptom onset. [cir] Age at symptom onset.
[cir] Social determinants of [cir] Social determinants of
health, including education level, health, including education
socioeconomic status, immigration level, socioeconomic status,
status, refugee status, and immigration status, refugee
geography (e.g., urban vs. rural). status, and geography (e.g.,
urban vs. rural).
[[Page 58584]]
[cir] Diagnosis of PANS/PANDAS. [cir] Diagnosis of PANS/PANDAS.
[cir] OCD in first degree [cir] OCD in first degree
relatives. relatives.
[cir] Level of family [cir] Level of family
accommodation. accommodation.
[cir] Co-occurring disorders (e.g., [cir] Co-occurring disorders
major depressive disorder, anxiety (e.g., major depressive disorder,
disorders, attention-deficit anxiety disorders, attention-
hyperactivity disorder, conduct deficit hyperactivity disorder,
disorders, autism spectrum conduct disorders, autism
disorder, and Tourette syndrome, spectrum disorder, and Tourette
other tic disorders). syndrome, other tic disorders).
[cir] Diagnosis during COVID-19 [cir] Diagnosis during COVID-19
pandemic (as defined by study pandemic (as defined by study
authors). authors).
[cir] Primary versus specialist [cir] Duration of symptoms prior
care. to treatment.
Respondent type. [cir] Symptom severity.
[cir] In-session exposure and
response prevention.
Exclude: [cir] Medication dose.
Neuroimaging, e.g., [cir] Care settings and care
functional MRI. intensities.
...................................... [ssquf] Traditional outpatient.
...................................... [ssquf] Intensive outpatient.
...................................... Day programs (e.g.,
partial hospitalization).
...................................... Residential.
...................................... [ssquf] Inpatient.
...................................... [ssquf] Other care settings,
including school-based
settings.
...................................... [ssquf] Telehealth (vs. in-
person).
[ssquf] Primary versus specialist
care.
Design........................... Cohort or cross-sectional studies: Comparative trials:
comparing an index test(s) to Randomized controlled
a reference standard. trials.
comparing an index test(s) in Nonrandomized comparative
two or more subgroups of interest. studies.
comparing two or more [cir] prospective or retrospective
diagnostic strategies. with appropriate adjustment for
confounding.
Randomized controlled trials. Single arm studies, N >= 50:
Nonrandomized comparative studies: with multivariable analyses
prospective or retrospective of potential effect modifiers/
with appropriate adjustment for subgroups of interest.
confounding.
Systematic reviews (for reference Systematic reviews (for reference
lists only). lists only).
Exclude: Exclude:
Prevalence studies. Cross-sectional studies (no
Qualitative studies. longitudinal follow-up).
Case reports and case series. Qualitative studies.
Unpublished studies, Case reports and case
including conference abstracts (but series.
include studies with reported results Unpublished studies,
in the ClinicalTrials.gov database). including conference abstracts (but
include studies with reported
results in the ClinicalTrials.gov
database).
Timing........................... Any. Any.
Setting.......................... Any, including administration of Any.
test(s) in-person or via tele-health.
----------------------------------------------------------------------------------------------------------------
* Prioritized outcome.
Dated: August 21, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023-18415 Filed 8-25-23; 8:45 am]
BILLING CODE 4160-90-P
