Notice2022-15112
Supplemental Evidence and Data Request on ADHD Diagnosis and Treatment in Children and Adolescents
Primary source
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Published
July 15, 2022
Issuing agencies
Health and Human Services DepartmentAgency for Healthcare Research and Quality
Abstract
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on ADHD Diagnosis and Treatment in Children and Adolescents, 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.
Full Text
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<title>Federal Register, Volume 87 Issue 135 (Friday, July 15, 2022)</title>
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[Federal Register Volume 87, Number 135 (Friday, July 15, 2022)]
[Notices]
[Pages 42465-42468]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-15112]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on ADHD Diagnosis and
Treatment in Children and Adolescents
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for Supplemental Evidence and Data Submissions.
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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is
seeking scientific information submissions from the public. Scientific
information is being solicited to inform our review on ADHD Diagnosis
and Treatment in Children and Adolescents, 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Access to published and unpublished pertinent scientific information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 August 15, 2022.
ADDRESSES:
Email submissions: <a href="/cdn-cgi/l/email-protection#d0b5a0b390b1b8a2a1feb8b8a3feb7bfa6"><span class="__cf_email__" data-cfemail="bcd9ccdffcddd4cecd92d4d4cf92dbd3ca">[email protected]</span></a>.
Print submissions:
Mailing Address: Center for Evidence and Practice Improvement,
Agency for Healthcare Research and Quality, ATTN: EPC SEADs
Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
Shipping Address (FedEx, UPS, etc.): Center for Evidence and
Practice Improvement, Agency for Healthcare Research and Quality, ATTN:
EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496
or Email: <a href="/cdn-cgi/l/email-protection#0e6b7e6d4e6f667c7f2066667d20696178"><span class="__cf_email__" data-cfemail="2c495c4f6c4d445e5d0244445f024b435a">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Evidence-based Practice Center (EPC)
Program to complete a review of the evidence for ADHD Diagnosis and
Treatment in Children and Adolescents. AHRQ is conducting this
systematic review pursuant to Section 902 of the Public Health Service
Act, 42 U.S.C. 299a.
The EPC Program is dedicated to identifying as many studies as
possible that are relevant to the questions for each of its reviews. In
order to do so, we are supplementing the usual manual and electronic
database searches of the literature by requesting information from the
public (e.g., details of studies conducted). We are looking for studies
that report on ADHD Diagnosis and Treatment in Children and
Adolescents, including those that describe adverse events. The entire
research protocol is available online at: <a href="https://effectivehealthcare.ahrq.gov/products/attention-deficit-hyperactivity-disorder/protocol">https://effectivehealthcare.ahrq.gov/products/attention-deficit-hyperactivity-disorder/protocol</a>.
This is to notify the public that the EPC Program would find the
following information on ADHD Diagnosis and Treatment in Children and
Adolescents helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this indication. In the list, please indicate whether
results are available on <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> along with the
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> trial number.
[ssquf] For completed studies that do not have results on
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>, 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.
[ssquf] A list of ongoing studies that your organization has
sponsored for this indication. In the list, please provide the
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> 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.
[ssquf] 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 is very beneficial to the Program. Materials
submitted must be publicly available or able to be made public.
Materials that are considered confidential; marketing materials; study
types not included in the review; or information on 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.
[[Page 42466]]
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: <a href="https://www.effectivehealthcare.ahrq.gov/email-updates">https://www.effectivehealthcare.ahrq.gov/email-updates</a>.
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.
Key Questions (KQ)
KQ1: For the diagnosis of ADHD:
<bullet> What is the comparative diagnostic accuracy of approaches
that can be used in the primary care practice setting or by specialists
to diagnose ADHD among individuals younger than 7 years of age?
<bullet> What is the comparative diagnostic accuracy of EEG,
imaging, or approaches assessing executive function that can be used in
the primary care practice setting or by specialists to diagnose ADHD
among individuals aged 7 through 17?
<bullet> For both populations, how does the comparative diagnostic
accuracy of these approaches vary by clinical setting, including
primary care or specialty clinic, or patient subgroup, including age,
sex, or other risk factors associated with ADHD?
<bullet> What are the adverse effects associated with being labeled
correctly or incorrectly as having ADHD?
KQ2: What are the comparative safety and effectiveness of
pharmacologic and/or nonpharmacologic treatments of ADHD in improving
outcomes associated with ADHD?
<bullet> How do these outcomes vary by presentation (inattentive,
hyperactive/impulsive, and combined) or other comorbid conditions?
<bullet> What is the risk of diversion of pharmacologic treatment?
KQ 3: What are the comparative safety and effectiveness of
different empirical monitoring strategies to evaluate the effectiveness
of treatment in improving ADHD symptoms or other long-term outcomes?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and Setting)
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PICOTS element Inclusion criteria Exclusion criteria
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Population....................... KQ 1 (diagnosis): Individuals birth KQ 1, KQ 2: Individuals 18 years of
through 17 years of age without the age or older unless findings are
diagnosis of ADHD. reported separately for individuals
KQ 2 (treatment): Individuals birth 18 years and under, or if the mean
through 17 years of age with a patient age plus the standard
diagnosis of ADHD. deviation is not greater than 21
KQ 3 (monitoring): Individuals birth years of age.
through 17 years of age who have KQ 3: For long-term studies, the age
previously begun treatment for ADHD. of the individuals may be greater
than 17, but these studies are only
considered for inclusion if the age
at enrollment in the study was 18
years or younger, and administrative
claims data used for diagnosis of
ADHD.
Interventions.................... KQ 1 (diagnosis): Any standard ADHD KQ 1: Validation studies or diagnosis
diagnostic strategy, including conducted using a non-validated
clinician interview, standardized instrument.
instrument (e.g., Vanderbilt scales, KQ 2: Studies comparing pharmacologic
Conner scales, SNAP-IV rating score), agents approved by the FDA for the
neuropsychological test measures treatment of ADHD that have
(e.g., working memory, processing enrollment of fewer than 100
speed, continuous performance tasks) patients with ADHD, or less than 6
for individuals under 7 years of age. months of follow-up.
The use of EEG-based systems,
imaging, or assessment of executive
function for the diagnosis of ADHD in
individuals through 17 years.
KQ 2 (treatment): Any pharmacologic or
nonpharmacologic treatment of ADHD,
alone or in combination:
<bullet> Pharmacologic treatments .....................................
considered are brand name and generic
formulations of FDA-approved
stimulants (methylphenidate,
amphetamine) and non-stimulants
(norepinephrine reuptake inhibitors,
alpha agonists) and other suggested
treatments, including
methylphenidate, dexmethylphenidate,
dextroamphetamine, lisdexamfetamine,
mixed amphetamine salts, amphetamine,
tricyclic antidepressants,
desipramine, nortriptyline, selective
norepinephrine reuptake inhibitors,
atomoxetine, alpha-2 agonists,
clonidine, guanfacine, dopamine
reuptake inhibitors, modafinil,
armodafinil, norepinephrine-dopamine
reuptake inhibitors, bupropion,
serotonin-norepinephrine reuptake
inhibitors, duloxetine, serotonin-
norepinephrine-dopamine reuptake
inhibitors, venlafaxine, monoamine
oxidase type B inhibitors,
selegiline, N-methyl-D-aspartate
receptor antagonists, amantadine,
memantine.
[[Page 42467]]
<bullet> Nonpharmacologic therapies .....................................
considered include psychosocial
interventions, behavioral
interventions, cognitive behavioral
therapy, digital gamified cognitive
therapies, EndeavorRx, play therapy,
play-based interventions, mindfulness-
based therapies, school
interventions, cognitive training
therapies, biofeedback or
neurofeedback, parent behavior
training, dietary supplements (e.g.,
omega-3 fatty acids, vitamins, herbal
supplements, probiotics), homeopathy,
acupuncture, elimination diets,
vision training, exercise,
chiropractic treatment, peer
interventions, and Monarch external
trigeminal nerve stimulation (eTNS)
system.
KQ 3 (monitoring): Follow-up visits in .....................................
primary care using various methods
and frequencies (monthly to annually)
for monitoring, independent of
treatment, including the selection of
scales/validated tools for monitoring
of ADHD severity and treatment
response along with forms of remote
monitoring or telehealth strategies.
Comparators...................... KQ 1 (diagnosis): Confirmation of KQ 1: Comparison to diagnosis with a
diagnosis by a specialist (gold non-validated instrument.
standard), such as a psychologist,
psychiatrist or other care provider
using a well-validated and reliable
process of confirming the diagnosis
of ADHD according to the DSM-5.
KQ 2 (treatment): Specific treatments KQ 2: Comparisons to other patient
compared with other treatments as groups rather than treatments.
described above or to no treatment.
KQ 3 (monitoring): Follow-up compared .....................................
with differing frequencies of follow-
up or different settings of follow-up
for monitoring strategies; no
restrictions for long-term outcomes.
Outcomes......................... KQ 1 (diagnosis): .....................................
<bullet> Accuracy of diagnostic .....................................
strategy, as measured by: diagnostic
concordance of primary care provider
with specialist, inter-rater
reliability, internal consistency,
test-retest, sensitivity,
specificity, area under the curve,
positive predictive value, negative
predictive value, false positives,
false negatives.
<bullet> Risk of misdiagnosis, missed .....................................
condition that can appear as ADHD
Labeling is any measure of stigma
following diagnosis comparing those
with and without ADHD.
<bullet> Costs. .....................................
KQ 2 (treatment): .....................................
<bullet> Intermediate outcomes: .....................................
[cir] Changes on standardized symptom .....................................
scores, including narrow-band focused
instruments (Vanderbilt rating
scales, ADHD Rating Scales such as
the Strength and Weaknesses of
Attention-Deficit/Hyperactivity
Disorder Symptoms [SWAN]) and broad-
band scales (Child Behavior Checklist
and Teacher Report Form, Behavior
Assessment System for Children,
Conners' Rating Scales-Revised,
Conners' 3 Parent, Conners' 3
Teacher).
[cir] Progress toward patient- .....................................
identified goals.
[cir] Executive functioning measure .....................................
changes.
[cir] Functional impairment (assessed .....................................
using the Clinical Global Impressions
[CGI] scale of the Impairment Rating
Scale [IRS]).
[cir] Acceptability of treatment. .....................................
<bullet> Final outcomes: .....................................
[cir] Academic performance (Academic .....................................
Performance Rating Scale Academic
Competency Evaluation Scale (ACES),
school grades, grade retention/not
being promoted, Vanderbilt Teacher
Form Academic Performance Subscale,
standardized achievement tests (WIAT,
WJ, WRAT).
[[Page 42468]]
[cir] Workforce participation, quality .....................................
of peer relationships, divorce/
relationship status, motor vehicle
collisions or other accidents, motor
vehicle violations, risk-taking
behaviors, incarceration or other
interactions with the legal system
(juvenile detention, probation, court-
mandated interventions, need for
residential placement).
[cir] Obesity, tobacco use, substance .....................................
abuse, mood disorders, depression or
anxiety, self-injurious non-suicidal
behavior, suicide (attempted or
completed), suicidal ideation,
mortality.
[cir] Potential adverse effects of .....................................
treatment, including changes in
appetite, growth suppression, weight
decrease, sleep disturbance,
gastrointestinal symptoms, elevated
blood pressure, increased heart rate,
risk of sudden cardiac death, cardiac
arrhythmias, conduction
abnormalities, chemical leukoderma;
priapism, tics or other movement
disorders, hallucination, aggression,
behavior changes, personality change,
loss of spontaneity, number of
adverse events.
[cir] Overtreatment, diversion and .....................................
misuse of pharmacotherapy, parental
stress, time demands/opportunity
cost.
KQ 3 (monitoring): .....................................
<bullet> Changes in treatment or dose. .....................................
<bullet> Adverse effects of treatment. .....................................
<bullet> Changes in intermediate and .....................................
final outcomes.
Timing........................... KQ 1 (diagnosis): .....................................
<bullet> For assessment of diagnostic .....................................
accuracy: diagnostic follow-up must
be within 4 months of the initial
evaluation and must be completed
before treatment is initiated.
<bullet> For labeling: any time after .....................................
the ADHD diagnosis.
KQ 2 (treatment) and KQ 3 .....................................
(monitoring): Any.
Setting.......................... KQ 1 (diagnosis): Primary or specialty .....................................
care settings.
KQ 2 (treatment) and KQ 3
(monitoring): Any (including remote
monitoring and telehealth).
Study Design..................... <bullet> Original data. Editorials, nonsystematic reviews,
KQ 1-3: Randomized controlled trials letters, case series, case reports,
(RCTs). abstract-only, pre-post studies.
KQ 1 (diagnosis): For diagnostic Because studies with fewer than 20
accuracy, observational studies, subjects are often pilot studies or
including cross-sectional studies, studies of lower quality, these are
are eligible if they include patients excluded. Given the research volume
with diagnostic uncertainty and on pharmacologic treatment the
direct comparison of diagnosis in sample size limit for non-RCTs is
primary care to diagnosis by a 100 participants, representing
specialist. population study sizes that could
KQ 1 (diagnosis) and KQ 2 (treatment): substantially impact the assessment
controlled clinical trials and of the existing evidence base.
prospective and retrospective Systematic reviews are not eligible
observational studies with for inclusion but will be retained.
comparator; sample size:
<bullet> >=20 participants.
<bullet> >=100 participants for
studies comparing two or more
pharmacologic treatments.
KQ 3 (monitoring): no study size
restriction.
Other limiters................... <bullet> English-language Non-English language and abbreviated
publications. publications (abstracts, letters).
<bullet> KQ 1 and KQ 2: Published in
or after 2016 and not included in the
prior AHRQ report on ADHD; in
addition, we will use studies
included in meta-analyses in the
prior report for cumulative meta-
analyses.
<bullet> KQ 3: Monitoring strategies .....................................
and long-term effects have no
publication year restriction.
<bullet> Journal manuscripts and trial
record data with results.
----------------------------------------------------------------------------------------------------------------
Note: FDA: Food and Drug Administration, KQ: Key Question.
Dated: July 11, 2022.
Marquita Cullom,
Associate Director.
[FR Doc. 2022-15112 Filed 7-14-22; 8:45 am]
BILLING CODE 4160-90-P
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