Supplemental Evidence and Data Request on Depression in Children: Systematic Review, 47616-47619 [2018-20481]

Download as PDF 47616 Federal Register / Vol. 83, No. 183 / Thursday, September 20, 2018 / Notices 1047TH—MEETING—Continued [Open Meeting September 20, 2018 10:00 p.m.] Item No. Docket No. Company OR18–12–000 .................... BP Products North America, Inc., Trafigura Trading LLC, and TCPU, Inc. v. Colonial Pipeline Company. TransMontaigne Product Services LLC v. Colonial Pipeline Company. CITGO Petroleum Corporation v. Colonial Pipeline Company. OR18–17–000 .................... OR18–21–000 .................... (consolidated) ..................... HYDRO H–1 ....................................... H–2 ....................................... EL18–56–000 ..................... P–12966–005 ..................... P–2611–087 ....................... Utah Board of Water Resources. Hydro-Kennebec LLC. CERTIFICATES C–1 ....................................... C–2 ....................................... CP09–465–002 .................. CP17–219–000 .................. Issued: September 13, 2018. Kimberly D. Bose, Secretary. [FR Doc. 2018–20619 Filed 9–18–18; 4:15 pm] BILLING CODE 6717–01–P amozie on DSK3GDR082PROD with NOTICES1 FEDERAL ELECTION COMMISSION Sunshine Act Meetings Tuesday, September 25, 2018 at 10:00 a.m. PLACE: 1050 First Street NE, Washington, DC. STATUS: This Meeting will be Closed to the Public. TIME AND DATE: 18:01 Sep 19, 2018 Compliance matters pursuant to 52 U.S.C. 30109. Matters concerning participation in civil actions or proceedings or arbitration. * * * * * CONTACT PERSON FOR MORE INFORMATION: Judith Ingram, Press Officer, Telephone: (202) 694–1220. MATTERS TO BE CONSIDERED: A free webcast of this event is available through http:// ferc.capitolconnection.org/. Anyone with internet access who desires to view this event can do so by navigating to www.ferc.gov’s Calendar of Events and locating this event in the Calendar. The event will contain a link to its webcast. The Capitol Connection provides technical support for the free webcasts. 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[FR Doc. 2018–20632 Filed 9–18–18; 4:15 pm] BILLING CODE 6715–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Supplemental Evidence and Data Request on Depression in Children: Systematic Review Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for Supplemental Evidence and Data Submissions. AGENCY: 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 of Depression in Children: Systematic Review, which is currently being conducted by the AHRQ’s Evidencebased 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 October 22, 2018. ADDRESSES: Email submissions: epc@ ahrq.hhs.gov. SUMMARY: PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 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: Jenae Benns, Telephone: 301–427–1496 or Email: epc@ahrq.hhs.gov. The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for Depression in Children: Systematic Review. AHRQ is conducting this systematic review pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a). 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 Depression in Children: Systematic Review, including those that describe adverse events. The entire research protocol, including the key questions, is also available online at: https://effectivehealthcare.ahrq.gov/ topic/childhood-depression/protocol This is to notify the public that the EPC Program would find the following SUPPLEMENTARY INFORMATION: E:\FR\FM\20SEN1.SGM 20SEN1 47617 Federal Register / Vol. 83, No. 183 / Thursday, September 20, 2018 / Notices information on Depression in Children: Systematic Review helpful: • A list of completed studies that your organization has sponsored for this indication. 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, please provide a summary, including the following elements: 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 indication. In the list, please provide the ClinicalTrials.gov trial number or, if the trial is not registered, the protocol for the study including 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 indication and an index outlining the relevant information in each submitted file. Your contribution will be very beneficial to the EPC 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 indications not included in the review cannot be used by the EPC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter. The draft of this review will be posted on AHRQ’s EPC Program website and available for public comment for a period of 4 weeks. If you would like to be notified when the draft is posted, please sign up for the email list at: https:// www.effectivehealthcare.ahrq.gov/ email-updates. The systematic review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions. The Key Questions (KQs) 1a. In adolescents and children, what are the benefits and harms of nonpharmacological interventions for depressive disorders (defined as MDD or PDD/DD)? 1b. How do these benefits and harms vary by subpopulation (e.g., patient characteristics, parent/caregiver characteristics, disorder characteristics, history of previous treatment, comorbid condition, exposure to a traumatic life event)? 2a. In adolescents and children, what are the benefits and harms of pharmacological interventions for depressive disorders (defined as MDD or PDD/DD)? 2b. How do the benefits and harms vary by subpopulation (e.g., patient characteristics, disorder characteristics, history of previous treatment, comorbid condition, exposure to a traumatic life event? 3a. In adolescents and children, what are the benefits and harms of combination interventions for depressive disorders (defined as MDD or PDD/DD)? 3b. How do the benefits and harms vary by subpopulation (e.g., patient characteristics, disorder characteristics, history of previous treatment, comorbid condition, exposure to a traumatic life event)? 4a: In adolescents and children, what are the benefits and harms of collaborative care interventions for depressive disorders (defined as MDD or PDD/DD)? 4b: How do the benefits and harms vary by subpopulation (e.g., patient characteristics, disorder characteristics, history of previous treatment, comorbid condition, exposure to a traumatic life event)? 5a: In adolescents and children, what are the comparative benefits and harms of treatments (pharmacological, nonpharmacological, combined, collaborative care interventions) for depressive disorders (defined as MDD or PDD/DD)? 5b. How do these benefits and harms vary by subpopulation (e.g., patient characteristics, disorder characteristics, history of previous treatment, comorbid condition, exposure to a traumatic life event)?PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, Settings) amozie on DSK3GDR082PROD with NOTICES1 TABLE 1—PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, SETTINGS) AND INCLUSION/ EXCLUSION CRITERIA PICOTS Inclusion Exclusion Population ....................................... Children and adolescents (≤18 years old) with a depressive disorder (MDD or PDD/DD) as indicated by a diagnosis made from an established taxonomy (e.g., DSM, ICD) via administration of a structured or semi-structured clinical interview (CIDI, DISC, SCID, PRIME–MD, Kinder-DIPS, K–SADS, DICA, CAS, SADS, DAWBA, SCAN), use of a cutpoint indicative of clinical MDD or PDD/DD as measured by a clinically validated depression scale (BDI, CDI, CESD, PHQ, MFQ, ChilD–S),* or via a clinician diagnosis. Subgroups of interest (KQs 1b, 2b, 3b, 4b, 5b) include those distinguished by patient characteristics (e.g., developmental age—child or adolescent, gender, race/ethnicity), parent/caregiver characteristics, disorder characteristics (e.g., type, severity), history of previous treatment, comorbid condition, and exposure to a traumatic life event. Nonpharmacological interventions: ........................................................ Psychological/psychosocial: Cognitive behavioral therapy, rational emotive behavior therapy, behavioral activation, other behavioral therapy, interpersonal therapy, directive counseling, Katathymimaginative Psychotherapy, family therapy, parent education, selfhelp groups, problem-solving therapy, autonomic training, combined-modality therapy, psychological adaptation therapies. All other children and adolescents (≤18 years old); all adults >18 years old. Intervention ...................................... VerDate Sep<11>2014 18:01 Sep 19, 2018 Jkt 244001 PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 E:\FR\FM\20SEN1.SGM All other interventions. 20SEN1 47618 Federal Register / Vol. 83, No. 183 / Thursday, September 20, 2018 / Notices TABLE 1—PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, SETTINGS) AND INCLUSION/ EXCLUSION CRITERIA—Continued PICOTS Inclusion Comparator ..................................... Outcomes **** .................................. Time frame ...................................... Settings ........................................... amozie on DSK3GDR082PROD with NOTICES1 Study design ................................... Language ........................................ Exclusion Lifestyle: Exercise (physical activity), diet therapy, mindfulness (including mindfulness-based stress reduction), meditation (including mindfulness mediation), relaxation therapy, massage therapy, music therapy, art therapy, integrative restoration, visualization, taichi, yoga, spirituality, acupuncture. Supplements: St. John’s Wort, SAMe, fish oil, melatonin, L-tryptophan, folic acid, 5–HTP, zinc, chromium, gingko biloba, vitamin E, omega-3 fatty acids, hypericum, inositol, selenium. Other: Electroconvulsive therapy, transcranial magnetic stimulation, light therapy (phototherapy), hypnotherapy (including self-hypnotherapy), neurofeedback, deep brain stimulation, biofeedback. Pharmacological interventions:. Selective serotonin reuptake inhibitors (SSRIs): Citalopram, escitalopram, fluvoxamine, paroxetine, sertraline, vilazodone. Serotonin and norepinephrine reuptake inhibitors (SNRIs): Duloxetine, venlafaxine. Tricyclic antidepressants: Amitriptyline, desipramine, imipramine, nortriptyline, doxepin, clomipramine. Monoamine oxidase inhibitors: Rasagiline, selegiline, isocarboxazid, phenelzine, tranylcypromine. Atypical antidepressants: Bupropion, mirtazapine, nefazodone, trazodone, vortioxetine. Combination interventions: Any combined treatment that includes two or more types of nonpharmacological, pharmacological, and/or collaborative care interventions, either started together or given as augments to initial treatment types. Collaborative care interventions: Collaborative care, integrated care, integrative care, stepped care, coordinated care, co-managed care, co-located care. KQ 1: Treatment as usual, sham, attention control, wait list control .... KQ 2: Placebo, treatment as usual, attention control, wait list control. KQ 3: Treatment as usual, placebo, sham, attention control, wait list control. KQ 4: Treatment as usual, placebo, sham, attention control, wait list control. KQ 5: Any nonpharmacologic, pharmacologic, or collaborative care intervention alone or in combination. Benefits: ................................................................................................. Remission. Response. Relapse. Depressive symptoms. Suicidality. Mortality. Functional impairment. Harms: ................................................................................................... Any AEs of intervention (e.g., death, serious adverse events). Any publication dates ............................................................................ At least 6 weeks of treatment. Outpatient care in countries with a very high Human Development Index **. For benefits: ........................................................................................... • Adolescents (sample age >12 and ≤18): randomized controlled trials (RCTs). • Children (sample age ≤12): RCTs or controlled clinical trials (CCTs). For harms: • RCTs, CCTs, and observational studies ***. Reference lists of relevant systematic reviews published in 2013 or later will be used to ensure our search strategies captured all relevant studies. Studies published in English ................................................................. All other comparators. All other outcomes. Less than 6 weeks of treatment. Inpatient care, studies conducted in countries without a very high Human Development Index. All other designs and studies using included designs that do not meet the sample size criterion. Studies published in languages other than English. * In the absence of clear, clinically validated cutoffs of depression scales used to indicate a either MDD or PDD/DD, the research team will consult two recent systematic reviews 1 2 on the topic and discuss required thresholds with the Technical Expert Panel (TEP) for each scale. ** http://hdr.undp.org/en/content/human-development-index-hdi. *** The research team will evaluate the yield for harms. When studies with sample sizes of 1,000 or more participants are available for a given intervention and comparator, the team plans to restrict the analysis to that group. If large samples are not available, the team plans to include studies with smaller sample sizes. VerDate Sep<11>2014 19:25 Sep 19, 2018 Jkt 244001 PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 E:\FR\FM\20SEN1.SGM 20SEN1 Federal Register / Vol. 83, No. 183 / Thursday, September 20, 2018 / Notices 47619 **** The research team anticipates grading all outcomes but if needed (based on the volume of evidence), they may seek input from the TEP on prioritizing outcomes for strength of evidence grading. AE = adverse event; BDI = Beck Depression Inventory; CAS: The Child Assessment Schedule; CBT = cognitive behavioral therapy; CCT = controlled clinical trial; CIDI = Composite International Diagnostic Interview; CDI = Children’s Depression Inventory; CES–D = Center for Epidemiological Studies Depression Scale; ChilD–S: Children’s Depression Screener; DAWBA = The Development and Wellbeing Assessment; DD = dysthymic disorder; DICA = Diagnostic Interview for Children and Adolescents; DISC = Diagnostic Interview Schedule for Children; DSM = Diagnostic and Statistical Manual; IPT = interpersonal therapy; Kinder-DIPS = The Diagnostic Interview for Psychiatric Disorders in Children and Adolescents; K–SADS = The Schedule for Affective Disorders and Schizophrenia for School-Age Children; MDD = major depressive disorder; MFQ = Mood and Feelings Questionnaire; PDD = persistent depressive disorder; PHQ = Patient Health Questionnaire; PICOTS = populations, interventions, comparators, outcomes, timing, and setting; PRIME–MD = The Primary Care Evaluation of Mental Disorders; RCT = randomized controlled trial; SADS = The Schedule for Affective Disorders and Schizophrenia; SCAN = Schedules for Clinical Assessment in Neuropsychiatry; SCID = Structured Clinical Interview for DSM disorders. References 1. Roseman M, Kloda LA, Saadat N, et al. Accuracy of Depression Screening Tools to Detect Major Depression in Children and Adolescents: A Systematic Review. Can J Psychiatry. 2016 Dec;61(12):746– 57. doi: 10.1177/0706743716651833. PMID: 27310247. 2. Stockings E, Degenhardt L, Lee YY, et al. Symptom screening scales for detecting major depressive disorder in children and adolescents: a systematic review and meta-analysis of reliability, validity and diagnostic utility. J Affect Disord. 2015 Mar 15;174:447–63. doi: 10.1016/ j.jad.2014.11.061. PMID: 25553406. Francis D. Chesley, Jr., Deputy Director. CDC Performance Review Boards or Panels, which will oversee the evaluation of performance appraisals of Senior Executive Service members for the Fiscal Year 2018 review period: Dean, Hazel Co-Chair Shelton, Dana Co-Chair Arispe, Irma Boyle, Coleen Branche, Christine Curlee, Robert C. Kosmos, Christine Peeples, Amy Qualters, Judith Ruiz, Roberto Smagh, Kalwant Dated: September 17, 2018. Sandra Cashman, Executive Secretary, Centers for Disease Control and Prevention. [FR Doc. 2018–20481 Filed 9–19–18; 8:45 am] BILLING CODE 4160–90–P [FR Doc. 2018–20445 Filed 9–19–18; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4163–18–P Centers for Disease Control and Prevention DEPARTMENT OF HEALTH AND HUMAN SERVICES Performance Review Board Members Centers for Medicare & Medicaid Services Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) is publishing the names of the Performance Review Board Members who are reviewing performance for Fiscal Year 2018. FOR FURTHER INFORMATION CONTACT: Sandra DeShields, Chief, Compensation and Performance Management Team, Executive and Scientific Resources Office, Human Resources Office, Centers for Disease Control and Prevention, 11 Corporate Square Blvd., Mailstop US11– 2, Atlanta, Georgia 30341, Telephone (770) 488–0252. SUPPLEMENTARY INFORMATION: Title 5, U.S.C. Section 4314(c)(4) of the Civil Service Reform Act of 1978, Public Law 95–454, requires that the appointment of Performance Review Board Members be published in the Federal Register. The following persons will serve on the amozie on DSK3GDR082PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 18:01 Sep 19, 2018 Jkt 244001 [CMS–4184–N] Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2019 Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2019. The calendar year 2019 AIC threshold amounts are $160 for ALJ hearings and $1,630 for judicial review. DATES: This annual adjustment is effective for requests for ALJ hearings and judicial review filed on or after January 1, 2019. SUMMARY: PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 Liz Hosna (Katherine.Hosna@cms.hhs.gov), (410) 786–4993. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: I. Background Section 1869(b)(1)(E) of the Social Security Act (the Act), as amended by section 521 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), established the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review at $100 and $1,000, respectively, for Medicare Part A and Part B appeals. Section 940 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), amended section 1869(b)(1)(E) of the Act to require the AIC threshold amounts for ALJ hearings and judicial review to be adjusted annually. Beginning in January 2005, the AIC threshold amounts are to be adjusted by the percentage increase in the medical care component of the consumer price index (CPI) for all urban consumers (U.S. city average) for July 2003 to July of the year preceding the year involved and rounded to the nearest multiple of $10. Section 940(b)(2) of the MMA provided conforming amendments to apply the AIC adjustment requirement to Medicare Part C/Medicare Advantage (MA) appeals and certain health maintenance organization and competitive health plan appeals. Health care prepayment plans are also subject to MA appeals rules, including the AIC adjustment requirement. Section 101 of the MMA provides for the application of the AIC adjustment requirement to Medicare Part D appeals. A. Medicare Part A and Part B Appeals The statutory formula for the annual adjustment to the AIC threshold amounts for ALJ hearings and judicial review of Medicare Part A and Part B appeals, set forth at section 1869(b)(1)(E) of the Act, is included in the applicable implementing regulations, 42 CFR 405.1006(b) and (c). The regulations require the Secretary of Health and Human Services (the E:\FR\FM\20SEN1.SGM 20SEN1

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[Federal Register Volume 83, Number 183 (Thursday, September 20, 2018)]
[Notices]
[Pages 47616-47619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20481]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Depression in Children: 
Systematic Review

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 of Depression in 
Children: Systematic Review, 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 October 22, 2018.

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: Jenae Benns, Telephone: 301-427-1496 
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 Depression in 
Children: Systematic Review. AHRQ is conducting this systematic review 
pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 
299a(a). 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 Depression in Children: Systematic Review, including 
those that describe adverse events. The entire research protocol, 
including the key questions, is also available online at: https://effectivehealthcare.ahrq.gov/topic/childhood-depression/protocol
    This is to notify the public that the EPC Program would find the 
following

[[Page 47617]]

information on Depression in Children: Systematic Review helpful:
     A list of completed studies that your organization has 
sponsored for this indication. 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, please provide a summary, including the following 
elements: 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 indication. In the list, please provide the 
ClinicalTrials.gov trial number or, if the trial is not registered, the 
protocol for the study including 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 indication and an index outlining the relevant information in each 
submitted file.
    Your contribution will be very beneficial to the EPC 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 
indications not included in the review cannot be used by the EPC 
Program. This is a voluntary request for information, and all costs for 
complying with this request must be borne by the submitter.
    The draft of this review will be posted on AHRQ's EPC Program 
website and available for public comment for a period of 4 weeks. If 
you would like to be notified when the draft is posted, please sign up 
for the email list at: https://www.effectivehealthcare.ahrq.gov/email-updates.
    The systematic review will answer the following questions. This 
information is provided as background. AHRQ is not requesting that the 
public provide answers to these questions.
    The Key Questions (KQs)
    1a. In adolescents and children, what are the benefits and harms of 
nonpharmacological interventions for depressive disorders (defined as 
MDD or PDD/DD)?
    1b. How do these benefits and harms vary by subpopulation (e.g., 
patient characteristics, parent/caregiver characteristics, disorder 
characteristics, history of previous treatment, comorbid condition, 
exposure to a traumatic life event)?
    2a. In adolescents and children, what are the benefits and harms of 
pharmacological interventions for depressive disorders (defined as MDD 
or PDD/DD)?
    2b. How do the benefits and harms vary by subpopulation (e.g., 
patient characteristics, disorder characteristics, history of previous 
treatment, comorbid condition, exposure to a traumatic life event?
    3a. In adolescents and children, what are the benefits and harms of 
combination interventions for depressive disorders (defined as MDD or 
PDD/DD)?
    3b. How do the benefits and harms vary by subpopulation (e.g., 
patient characteristics, disorder characteristics, history of previous 
treatment, comorbid condition, exposure to a traumatic life event)?
    4a: In adolescents and children, what are the benefits and harms of 
collaborative care interventions for depressive disorders (defined as 
MDD or PDD/DD)?
    4b: How do the benefits and harms vary by subpopulation (e.g., 
patient characteristics, disorder characteristics, history of previous 
treatment, comorbid condition, exposure to a traumatic life event)?
    5a: In adolescents and children, what are the comparative benefits 
and harms of treatments (pharmacological, nonpharmacological, combined, 
collaborative care interventions) for depressive disorders (defined as 
MDD or PDD/DD)?
    5b. How do these benefits and harms vary by subpopulation (e.g., 
patient characteristics, disorder characteristics, history of previous 
treatment, comorbid condition, exposure to a traumatic life 
event)?PICOTS (Populations, Interventions, Comparators, Outcomes, 
Timing, Settings)

   Table 1--PICOTS (Populations, Interventions, Comparators, Outcomes,
           Timing, Settings) and Inclusion/Exclusion Criteria
------------------------------------------------------------------------
            PICOTS                     Inclusion            Exclusion
------------------------------------------------------------------------
Population....................  Children and            All other
                                 adolescents (<=18       children and
                                 years old) with a       adolescents
                                 depressive disorder     (<=18 years
                                 (MDD or PDD/DD) as      old); all
                                 indicated by a          adults >18
                                 diagnosis made from     years old.
                                 an established
                                 taxonomy (e.g., DSM,
                                 ICD) via
                                 administration of a
                                 structured or semi-
                                 structured clinical
                                 interview (CIDI,
                                 DISC, SCID, PRIME-MD,
                                 Kinder-DIPS, K-SADS,
                                 DICA, CAS, SADS,
                                 DAWBA, SCAN), use of
                                 a cutpoint indicative
                                 of clinical MDD or
                                 PDD/DD as measured by
                                 a clinically
                                 validated depression
                                 scale (BDI, CDI,
                                 CESD, PHQ, MFQ, ChilD-
                                 S),* or via a
                                 clinician diagnosis.
                                Subgroups of interest
                                 (KQs 1b, 2b, 3b, 4b,
                                 5b) include those
                                 distinguished by
                                 patient
                                 characteristics
                                 (e.g., developmental
                                 age--child or
                                 adolescent, gender,
                                 race/ethnicity),
                                 parent/caregiver
                                 characteristics,
                                 disorder
                                 characteristics
                                 (e.g., type,
                                 severity), history of
                                 previous treatment,
                                 comorbid condition,
                                 and exposure to a
                                 traumatic life event.
Intervention..................  Nonpharmacological      All other
                                 interventions:.         interventions.
                                Psychological/
                                 psychosocial:
                                 Cognitive behavioral
                                 therapy, rational
                                 emotive behavior
                                 therapy, behavioral
                                 activation, other
                                 behavioral therapy,
                                 interpersonal
                                 therapy, directive
                                 counseling, Katathym-
                                 imaginative
                                 Psychotherapy, family
                                 therapy, parent
                                 education, self-help
                                 groups, problem-
                                 solving therapy,
                                 autonomic training,
                                 combined-modality
                                 therapy,
                                 psychological
                                 adaptation therapies.

[[Page 47618]]

 
                                Lifestyle: Exercise
                                 (physical activity),
                                 diet therapy,
                                 mindfulness
                                 (including
                                 mindfulness-based
                                 stress reduction),
                                 meditation (including
                                 mindfulness
                                 mediation),
                                 relaxation therapy,
                                 massage therapy,
                                 music therapy, art
                                 therapy, integrative
                                 restoration,
                                 visualization, tai-
                                 chi, yoga,
                                 spirituality,
                                 acupuncture.
                                Supplements: St.
                                 John's Wort, SAMe,
                                 fish oil, melatonin,
                                 L-tryptophan, folic
                                 acid, 5-HTP, zinc,
                                 chromium, gingko
                                 biloba, vitamin E,
                                 omega-3 fatty acids,
                                 hypericum, inositol,
                                 selenium.
                                Other:
                                 Electroconvulsive
                                 therapy, transcranial
                                 magnetic stimulation,
                                 light therapy
                                 (phototherapy),
                                 hypnotherapy
                                 (including self-
                                 hypnotherapy),
                                 neurofeedback, deep
                                 brain stimulation,
                                 biofeedback.
                                Pharmacological
                                 interventions:.
                                Selective serotonin
                                 reuptake inhibitors
                                 (SSRIs): Citalopram,
                                 escitalopram,
                                 fluvoxamine,
                                 paroxetine,
                                 sertraline,
                                 vilazodone.
                                Serotonin and
                                 norepinephrine
                                 reuptake inhibitors
                                 (SNRIs): Duloxetine,
                                 venlafaxine.
                                Tricyclic
                                 antidepressants:
                                 Amitriptyline,
                                 desipramine,
                                 imipramine,
                                 nortriptyline,
                                 doxepin, clomipramine.
                                Monoamine oxidase
                                 inhibitors:
                                 Rasagiline,
                                 selegiline,
                                 isocarboxazid,
                                 phenelzine,
                                 tranylcypromine.
                                Atypical
                                 antidepressants:
                                 Bupropion,
                                 mirtazapine,
                                 nefazodone,
                                 trazodone,
                                 vortioxetine.
                                Combination
                                 interventions: Any
                                 combined treatment
                                 that includes two or
                                 more types of
                                 nonpharmacological,
                                 pharmacological, and/
                                 or collaborative care
                                 interventions, either
                                 started together or
                                 given as augments to
                                 initial treatment
                                 types.
                                Collaborative care
                                 interventions:
                                 Collaborative care,
                                 integrated care,
                                 integrative care,
                                 stepped care,
                                 coordinated care, co-
                                 managed care, co-
                                 located care.
Comparator....................  KQ 1: Treatment as      All other
                                 usual, sham,            comparators.
                                 attention control,
                                 wait list control.
                                KQ 2: Placebo,
                                 treatment as usual,
                                 attention control,
                                 wait list control.
                                KQ 3: Treatment as
                                 usual, placebo, sham,
                                 attention control,
                                 wait list control.
                                KQ 4: Treatment as
                                 usual, placebo, sham,
                                 attention control,
                                 wait list control.
                                KQ 5: Any
                                 nonpharmacologic,
                                 pharmacologic, or
                                 collaborative care
                                 intervention alone or
                                 in combination.
Outcomes ****.................  Benefits:.............  All other
                                                         outcomes.
                                Remission.............
                                Response..............
                                Relapse...............
                                Depressive symptoms...
                                Suicidality...........
                                Mortality.............
                                Functional impairment.
                                Harms:................  ................
                                Any AEs of
                                 intervention (e.g.,
                                 death, serious
                                 adverse events).
Time frame....................  Any publication dates.  Less than 6
                                                         weeks of
                                                         treatment.
                                At least 6 weeks of
                                 treatment.
Settings......................  Outpatient care in      Inpatient care,
                                 countries with a very   studies
                                 high Human              conducted in
                                 Development Index **.   countries
                                                         without a very
                                                         high Human
                                                         Development
                                                         Index.
Study design..................  For benefits:.........  All other
                                 Adolescents     designs and
                                 (sample age >12 and     studies using
                                 <=18): randomized       included
                                 controlled trials       designs that do
                                 (RCTs).                 not meet the
                                 Children        sample size
                                 (sample age <=12):      criterion.
                                 RCTs or controlled
                                 clinical trials
                                 (CCTs).
                                For harms:              ................
                                 RCTs, CCTs,
                                 and observational
                                 studies ***.
                                Reference lists of
                                 relevant systematic
                                 reviews published in
                                 2013 or later will be
                                 used to ensure our
                                 search strategies
                                 captured all relevant
                                 studies.
Language......................  Studies published in    Studies
                                 English.                published in
                                                         languages other
                                                         than English.
------------------------------------------------------------------------
* In the absence of clear, clinically validated cutoffs of depression
  scales used to indicate a either MDD or PDD/DD, the research team will
  consult two recent systematic reviews 1 2 on the topic and discuss
  required thresholds with the Technical Expert Panel (TEP) for each
  scale.
** http://hdr.undp.org/en/content/human-development-index-hdi.
*** The research team will evaluate the yield for harms. When studies
  with sample sizes of 1,000 or more participants are available for a
  given intervention and comparator, the team plans to restrict the
  analysis to that group. If large samples are not available, the team
  plans to include studies with smaller sample sizes.

[[Page 47619]]

 
**** The research team anticipates grading all outcomes but if needed
  (based on the volume of evidence), they may seek input from the TEP on
  prioritizing outcomes for strength of evidence grading.
AE = adverse event; BDI = Beck Depression Inventory; CAS: The Child
  Assessment Schedule; CBT = cognitive behavioral therapy; CCT =
  controlled clinical trial; CIDI = Composite International Diagnostic
  Interview; CDI = Children's Depression Inventory; CES-D = Center for
  Epidemiological Studies Depression Scale; ChilD-S: Children's
  Depression Screener; DAWBA = The Development and Wellbeing Assessment;
  DD = dysthymic disorder; DICA = Diagnostic Interview for Children and
  Adolescents; DISC = Diagnostic Interview Schedule for Children; DSM =
  Diagnostic and Statistical Manual; IPT = interpersonal therapy; Kinder-
  DIPS = The Diagnostic Interview for Psychiatric Disorders in Children
  and Adolescents; K-SADS = The Schedule for Affective Disorders and
  Schizophrenia for School-Age Children; MDD = major depressive
  disorder; MFQ = Mood and Feelings Questionnaire; PDD = persistent
  depressive disorder; PHQ = Patient Health Questionnaire; PICOTS =
  populations, interventions, comparators, outcomes, timing, and
  setting; PRIME-MD = The Primary Care Evaluation of Mental Disorders;
  RCT = randomized controlled trial; SADS = The Schedule for Affective
  Disorders and Schizophrenia; SCAN = Schedules for Clinical Assessment
  in Neuropsychiatry; SCID = Structured Clinical Interview for DSM
  disorders.

References

1. Roseman M, Kloda LA, Saadat N, et al. Accuracy of Depression 
Screening Tools to Detect Major Depression in Children and 
Adolescents: A Systematic Review. Can J Psychiatry. 2016 
Dec;61(12):746-57. doi: 10.1177/0706743716651833. PMID: 27310247.
2. Stockings E, Degenhardt L, Lee YY, et al. Symptom screening 
scales for detecting major depressive disorder in children and 
adolescents: a systematic review and meta-analysis of reliability, 
validity and diagnostic utility. J Affect Disord. 2015 Mar 
15;174:447-63. doi: 10.1016/j.jad.2014.11.061. PMID: 25553406.

Francis D. Chesley, Jr.,
Deputy Director.
[FR Doc. 2018-20481 Filed 9-19-18; 8:45 am]
 BILLING CODE 4160-90-P