Supplemental Evidence and Data Request on Depression in Children: Systematic Review, 47616-47619 [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 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Access to published and unpublished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:
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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:
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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)
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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 ......................................
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All other interventions.
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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 ...........................................
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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.
** https://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.
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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.
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Dated: September 17, 2018.
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]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
** https://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]
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