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 Department of Health and Human Services Agency for Healthcare Research and Quality
 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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: epc@ahrq.hhs.gov.* *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: 
                        *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. 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: 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.* *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. *A list of ongoing studies that your organization has sponsored for this topic.*
                     In the list, please provide the 
                    ( print 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. 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):
                             • 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.
Children and adolescents (<21 years) with diagnosed OCD, including those with:
                             • possible PANS/PANDAS (with OCD). 
                             
                                • other comorbid conditions (
                                *e.g.,*
                                 autism).*Include:*
*Exclude:*• Studies evaluating only children and adolescents with OCD (to estimate test sensitivity alone).
• Children and adolescents diagnosed with other OCD-spectrum conditions (
                            *e.g.,*
                             body dysmorphic disorder, body focused repetitive behaviors) without an OCD diagnosis.*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).
• 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.Interventions
Index Test(s):
                             • Tools to diagnose OCD in symptomatic patients. For example,
Psychological interventions for OCD, alone or in combination with pharmacological and/or other interventions, including:○ Obsessive Compulsive Inventory-Child Version (OCI-CV-R).
                             ○ Toronto Obsessive-Compulsive Scale (TOCS). 
                             ○ 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).
• Cognitive behavioral therapy (CBT).
                             ○ Exposure and response prevention (ERP). 
                             ○ Psychoeducation. 
                             ○ Coping skills. 
                             ○ Cognitive therapy. 
                             • Acceptance and commitment therapy (ACT). 
                             • Targeted family interventions. 
                             • Other psychological interventions. 
                             • Delivery method. 
                             
                                ○ Therapist led, 
                                *e.g.,*
                                 scheduled, in-person, or via telephone, video conference.
                             
                             
                                ○ Self-guided, 
                                *e.g.,*
                                 asynchronous, therapist serves as supportive coach.*Exclude:*• Specific individual symptoms, behaviors, or characteristics.
                             • Genetic studies. 
                             • Biomarker studies.
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:○ SSRI augmentation with clomipramine, and other medications, including neuroleptics, nonsteroidal anti-inflammatory drugs (NSAIDs).○ 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).( print 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 assessment instruments (others may be included).
• Another active intervention or co-intervention (
                            *e.g.,*
                             relaxation therapy).○ Anxiety Disorders Interview Schedule for DSM-5 child version.
• Alternative delivery methods.○ (ADIS-C).○ Kiddie Schedule for Affective Disorders and Schizophrenia, Present and Lifetime version (K-SADS-PL) for DSM-5.○ Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).○ Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS).○ 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 have an asterisk and are in bold font)
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).
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).**Exclude:*• Studies not reporting predictive validity that report other psychometric properties of scales: for example, reliability or validity (content, construct, convergent, discriminant, divergent, face).
Functional impairment in school, social, and home/family domains:
                             • The Child Obsessive Compulsive Impact Scale—Revised (COIS-R).* 
                             ○ 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/Subgroups of interest
• Patient, family, social, and other characteristics, including:
                             ○ 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).
• Patient, family, social, and other characteristics, including:
                             ○ 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).○ Identity and Culture (
                            *e.g.,*
                             spiritual and religious beliefs and practices, native language, gender identity, sexual orientation, physical/mental disability status)
○ Identity and Culture (
                            *e.g.,*
                             spiritual and religious beliefs and practices, native language, gender identity, sexual orientation, physical/mental disability status).○ Age.
○ Age.○ Age at symptom onset.
○ Age at symptom onset.○ Social determinants of health, including education level, socioeconomic status, immigration status, refugee status, and geography (
                            *e.g.,*
                             urban vs. rural).
○ Social determinants of health, including education level, socioeconomic status, immigration status, refugee status, and geography (
                            *e.g.,*
                             urban vs. rural).( print page 58584)○ Diagnosis of PANS/PANDAS.
○ Diagnosis of PANS/PANDAS.○ OCD in first degree relatives.
○ OCD in first degree relatives.○ Level of family accommodation.
○ 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).
○ 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).○ Diagnosis during COVID-19 pandemic (as defined by study authors).
○ Diagnosis during COVID-19 pandemic (as defined by study authors).○ Primary versus specialist care.
                             • Respondent type.
○ Duration of symptoms prior to treatment.
                             ○ Symptom severity. 
                             ○ In-session exposure and response prevention.*Exclude:*
○ Medication dose.• Neuroimaging, 
                            *e.g.,*
                             functional MRI.
○ Care settings and care intensities.Traditional outpatient.Intensive outpatient.• Day programs (
                            *e.g.,*
                             partial hospitalization).• Residential.Inpatient.Other care settings, including school-based settings.Telehealth (vs. in-person).
                              Primary versus specialist care.Design
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.
Comparative trials:
                             • Randomized controlled trials. 
                             • Nonrandomized comparative studies. 
                             ○ prospective or retrospective with appropriate adjustment for confounding.Randomized controlled trials.
                             Nonrandomized comparative studies: 
                             • 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).
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).
*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).Timing
Any.
Any.Setting
Any, including administration of test(s) in-person or via tele-health.
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