Notice2023-18415
Supplemental Evidence and Data Request on Diagnosis and Management of Obsessive Compulsive Disorders in Children
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Published
August 28, 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 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.
Full Text
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<title>Federal Register, Volume 88 Issue 165 (Monday, August 28, 2023)</title>
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[Federal Register Volume 88, Number 165 (Monday, August 28, 2023)]
[Notices]
[Pages 58581-58584]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-18415]
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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.
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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 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 Access to published and unpublished pertinent scientific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: <a href="/cdn-cgi/l/email-protection#c9acb9aa89a8a1bbb8e7a1a1bae7aea6bf"><span class="__cf_email__" data-cfemail="d9bca9ba99b8b1aba8f7b1b1aaf7beb6af">[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#2045504360414852510e4848530e474f56"><span class="__cf_email__" data-cfemail="4d283d2e0d2c253f3c6325253e632a223b">[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 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: <a href="https://effectivehealthcare.ahrq.gov/products/obsessive-compulsive-disorder/protocol">https://effectivehealthcare.ahrq.gov/products/obsessive-compulsive-disorder/protocol</a>.
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 <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
[[Page 58582]]
<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 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: <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)
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)
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Key Question 1 (diagnosis of OCD) Key Question 2 (treatment of OCD)
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Population....................... Children and adolescents (<21 years): Children and adolescents (<21 years)
<bullet> in whom there is clinical with diagnosed OCD, including those
consideration of OCD. with:
<bullet> diagnosed with OCD and/or <bullet> possible PANS/PANDAS (with
other conditions which may be either OCD).
be comorbid with OCD or may present <bullet> other comorbid conditions
with similar symptoms. (e.g., autism).
Include: Exclude:
<bullet> Studies evaluating only <bullet> 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: <bullet> Subclinical OCD or obsessive
<bullet> Studies that include both or compulsive symptoms without an
adults and children that do not OCD diagnosis.
explicitly report a pediatric or <bullet> Studies that include both
adolescent subgroup in the abstract. adults and children that do not
<bullet> 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,
<bullet> Tools to diagnose OCD in alone or in combination with
symptomatic patients. For example, pharmacological and/or other
interventions, including:
[cir] Obsessive Compulsive <bullet> 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.
<bullet> Diagnostic prediction models. <bullet> Acceptance and commitment
<bullet> Must report use of specific therapy (ACT).
cut-point(s) to classify an <bullet> Targeted family
individual as having OCD or a interventions.
prediction algorithm or model to <bullet> Other psychological
predict the probability of OCD. interventions.
<bullet> Alternative administration <bullet> 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:
<bullet> Specific individual symptoms, Pharmacological interventions, alone
behaviors, or characteristics. or in combination with psychological
<bullet> Genetic studies. interventions:
<bullet> Biomarker studies. <bullet> Selective serotonin reuptake
inhibitors (SSRIs).
<bullet> Tricyclic antidepressants
(TCA), including clomipramine.
...................................... <bullet> Serotonin and norepinephrine
reuptake inhibitors (SNRIs).
...................................... <bullet> 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).
...................................... <bullet> Other pharmacologic
interventions, alone or in
combination with psychological and/
or other interventions, including
dose escalation, longer treatment
duration.
...................................... Neuromodulation interventions:
...................................... <bullet> Transcranial magnetic
stimulation (TMS),
...................................... <bullet> Transcranial direct current
stimulation (tDCS),
...................................... <bullet> Transcranial alternating
current stimulation (tACS),
...................................... <bullet> Deep brain stimulation
(DBS).
...................................... Complementary/integrative therapies:
...................................... <bullet> Naturopathic interventions.
...................................... <bullet> Mind-body practices (e.g.,
mindfulness, meditation, yoga).
...................................... <bullet> Sensory integration (e.g.,
deep pressure).
[[Page 58583]]
...................................... Exclude:
...................................... <bullet> Specific treatments for PANS/
PANDAS (e.g., antibiotics,
immunomodulation, intravenous
immunoglobulin).
Comparators...................... Reference standard(s): <bullet> No treatment (e.g., waitlist
control).
<bullet> Clinical interview. <bullet> Pill placebo or sham
control.
<bullet> Validated diagnostic <bullet> Another active intervention
assessment instruments (others may be or co-intervention (e.g., relaxation
included). therapy).
[cir] Anxiety Disorders Interview <bullet> 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).
<bullet> Different index tests (if
also compared with reference
standard).
<bullet> Different reference standards
(i.e., comparison of reference
standards).
<bullet> Different respondents (e.g.,
clinician, self, parent, educator).
<bullet> Different methods to give
test (e.g., in person vs. via tele-
health).
<bullet> Different populations (see
effect modifiers below).
Outcomes (prioritized outcomes OCD diagnosis: OCD symptom severity:
have an asterisk and are in bold <bullet> Sensitivity/Specificity.* <bullet> Children's Yale-Brown
font). <bullet> Positive and negative Obsessive Compulsive Scale Total (CY-
likelihood ratios. BOCS).*
<bullet> Accuracy. <bullet> Clinical Global Impression-
<bullet> Area under the Receiver Severity (CGI-S).*
Operator Characteristic Curve (AUC Treatment response and remission:
ROC). <bullet> Clinical remission
<bullet> Predicted probability of OCD (posttreatment CY-BOCS total score
(model calibration/discrimination). <=12 as defined by Farhat et. al.23,
<bullet> Time to initiation of or as reported).*
treatment (cohort studies). <bullet> Clinical Global Impression-
Improvement (CGI-I).*
Exclude:
<bullet> Studies not reporting Functional impairment in school,
predictive validity that report other social, and home/family domains:
psychometric properties of scales: <bullet> 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:
...................................... <bullet> Family Accommodation Scale
(FAS).*
...................................... Family functioning:
...................................... <bullet> OCD Family Functioning
Scale.
...................................... <bullet> Family Environment Scale
(FES).
...................................... <bullet> Parental Attitudes and
Behaviors Scale (PABS).
...................................... Patient/parent reported experience
measures (PREMs).
...................................... Patient reported outcome measure
(PROMs):
...................................... <bullet> Top Problems assessment
(TPA).
...................................... Quality of Life (QoL) General and
Health Related (HRQoL) (validated
scales only): *
...................................... <bullet> Quality of Life Enjoyment
and Satisfaction Questionnaire-Short
Form (QLESQ).
...................................... Acceptability of treatment: *
...................................... <bullet> Parental satisfaction with
services.
...................................... <bullet> Withdrawals/discontinuation.
...................................... Sleep-related problems.
...................................... Suicidal thoughts and behavior:
...................................... <bullet> Columbia Suicide Severity
Rating Scale Recent Self-Report
Screener (C-SSRS).
...................................... Anxiety and depression.
...................................... Adverse events related to treatment.*
...................................... Exclude:
...................................... <bullet> Neuroimaging (e.g.,
functional MRI).
Potential Effect Modifiers/ <bullet> Patient, family, social, and <bullet> 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.
<bullet> Respondent type. [cir] Symptom severity.
[cir] In-session exposure and
response prevention.
Exclude: [cir] Medication dose.
<bullet> Neuroimaging, e.g., [cir] Care settings and care
functional MRI. intensities.
...................................... [ssquf] Traditional outpatient.
...................................... [ssquf] Intensive outpatient.
...................................... <bullet> Day programs (e.g.,
partial hospitalization).
...................................... <bullet> 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:
<bullet> comparing an index test(s) to <bullet> Randomized controlled
a reference standard. trials.
<bullet> comparing an index test(s) in <bullet> Nonrandomized comparative
two or more subgroups of interest. studies.
<bullet> 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: <bullet> with multivariable analyses
<bullet> 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:
<bullet> Prevalence studies. <bullet> Cross-sectional studies (no
<bullet> Qualitative studies. longitudinal follow-up).
<bullet> Case reports and case series. <bullet> Qualitative studies.
<bullet> Unpublished studies, <bullet> Case reports and case
including conference abstracts (but series.
include studies with reported results <bullet> Unpublished studies,
in the <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> database). including conference abstracts (but
include studies with reported
results in the <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>
database).
Timing........................... Any. Any.
Setting.......................... Any, including administration of Any.
test(s) in-person or via tele-health.
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* 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
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