[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]


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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 Access to published and unpublished pertinent scientific 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#fe9b8e9dbe9f968c8fd096968dd0999188"><span class="__cf_email__" data-cfemail="dcb9acbf9cbdb4aeadf2b4b4aff2bbb3aa">[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="3b5e4b587b5a53494a15535348155c544d">[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: 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)
                                   <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 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


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