[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.

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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 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published and unpublished pertinent scientific information will improve 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