Federal Register / Vol. 87, No. 135 / Friday, July 15, 2022 / Notices 42465 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Notice of Meeting 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Notice. 

SUMMARY: The Agency for Healthcare 

Research and Quality (AHRQ) 

announces a Special Emphasis Panel 

(SEP) meeting on ‘‘Consumer 

Assessment of Healthcare Providers and 

Systems (CAHPS) VI (U18)’’. This SEP 

meeting will be closed to the public. 

DATES: July 22, 2022. 

ADDRESSES: Agency for Healthcare 

Research and Quality, (Video Assisted 

Review), 5600 Fishers Lane, Rockville, 

Maryland 20857. 

FOR FURTHER INFORMATION CONTACT: 

Jenny Griffith, Committee Management 

Officer, Office of Extramural Research, 

Education and Priority Populations, 

Agency for Healthcare Research and 

Quality, (AHRQ), 5600 Fishers Lane, 

Rockville, Maryland 20857, Telephone: 

(301) 427–1557. 

SUPPLEMENTARY INFORMATION: A Special 

Emphasis Panel is a group of experts in 

fields related to health care research 

who are invited by AHRQ, and agree to 

be available, to conduct on an as needed 

basis, scientific reviews of applications 

for AHRQ support. Individual members 

of the Panel do not attend regularly 

scheduled meetings and do not serve for 

fixed terms or a long period of time. 

Rather, they are asked to participate in 

particular review meetings which 

require their type of expertise. 

The SEP meeting referenced above 

will be closed to the public in 

accordance with the provisions set forth 

in 5 U.S.C. App. 2, section 10(d), 5 

U.S.C. 552b(c)(4), and 5 U.S.C. 

552b(c)(6). Grant applications for 

‘‘Consumer Assessment of Healthcare 

Providers and Systems (CAHPS) VI 

(U18)’’ are to be reviewed and discussed 

at this meeting. The grant applications 

and the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. Agenda 

items for this meeting are subject to 

change as priorities dictate. 

Dated: July 11, 2022. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2022–15113 Filed 7–14–22; 8:45 am] 

BILLING CODE 4160–90–P 

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. 

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: epc@

ahrq.hhs.gov. 

Print submissions: 

Mailing Address: Center for Evidence 

and Practice Improvement, Agency for 

Healthcare Research and Quality, 

ATTN: EPC SEADs Coordinator, 5600 

Fishers Lane, Mail Stop 06E53A, 

Rockville, MD 20857. 

Shipping Address (FedEx, UPS, etc.): 

Center for Evidence and Practice 

Improvement, Agency for Healthcare 

Research and Quality, ATTN: EPC 

SEADs Coordinator, 5600 Fishers Lane, 

Mail Stop 06E77D, Rockville, MD 

20857. 

FOR FURTHER INFORMATION CONTACT: 

Jenae Benns, Telephone: 301–427–1496 

or Email: epc@ahrq.hhs.gov. 

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: https://

effectivehealthcare.ahrq.gov/products/ 

attention-deficit-hyperactivity-disorder/ 

protocol. 

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: 

D 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. 

D For completed studies that do not 

have results on ClinicalTrials.gov, 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. 

D 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. 

D 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. 


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42466 Federal Register / Vol. 87, No. 135 / Friday, July 15, 2022 / Notices 

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. 

Key Questions (KQ) 

KQ1: For the diagnosis of ADHD: 

• 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? 

• 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? 

• 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? 

• 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? 

• How do these outcomes vary by 

presentation (inattentive, hyperactive/ 

impulsive, and combined) or other 

comorbid conditions? 

• 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) 

PICOTS element Inclusion criteria Exclusion criteria 

Population ............................ KQ 1 (diagnosis): Individuals birth through 17 years of 

age without the diagnosis of ADHD. 

KQ 2 (treatment): Individuals birth through 17 years of 

age with a diagnosis of ADHD. 

KQ 3 (monitoring): Individuals birth through 17 years of 

age who have previously begun treatment for ADHD. 

KQ 1, KQ 2: Individuals 18 years of age or older unless 

findings are reported separately for individuals 18 

years and under, or if the mean patient age plus the 

standard deviation is not greater than 21 years of 

age. 

KQ 3: For long-term studies, the age 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 diagnostic strategy, including clinician interview, standardized instrument (e.g., Vanderbilt scales, Conner scales, SNAP– 

IV rating score), neuropsychological test measures 

(e.g., working memory, processing speed, continuous 

performance tasks) for individuals under 7 years of 

age. 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: 

KQ 1: Validation studies or diagnosis conducted using 

a non-validated instrument. 

KQ 2: Studies comparing pharmacologic agents approved by the FDA for the treatment of ADHD that 

have enrollment of fewer than 100 patients with 

ADHD, or less than 6 months of follow-up. 

• Pharmacologic treatments considered are brand 

name and generic formulations of FDA-approved 

stimulants (methylphenidate, amphetamine) and nonstimulants (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, serotoninnorepinephrine reuptake inhibitors, duloxetine, serotonin-norepinephrine-dopamine reuptake inhibitors, 

venlafaxine, monoamine oxidase type B inhibitors, 

selegiline, N-methyl-D-aspartate receptor antagonists, 

amantadine, memantine. 


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Federal Register / Vol. 87, No. 135 / Friday, July 15, 2022 / Notices 42467 

PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)—Continued 

PICOTS element Inclusion criteria Exclusion criteria 

• 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 diagnosis by a specialist (gold 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 1: Comparison to diagnosis with a non-validated instrument. 

KQ 2 (treatment): Specific treatments compared with 

other treatments as described above or to no treatment. 

KQ 2: Comparisons to other patient groups rather than 

treatments. 

KQ 3 (monitoring): Follow-up compared with differing 

frequencies of follow-up or different settings of followup for monitoring strategies; no restrictions for longterm outcomes. 

Outcomes ............................. KQ 1 (diagnosis): 

• 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. 

• Risk of misdiagnosis, missed condition that can appear as ADHD Labeling is any measure of stigma following diagnosis comparing those with and without 

ADHD. 

• Costs. 

KQ 2 (treatment): 

• Intermediate outcomes: 

Æ 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). 

Æ Progress toward patient-identified goals. 

Æ Executive functioning measure changes. 

Æ Functional impairment (assessed using the Clinical 

Global Impressions [CGI] scale of the Impairment 

Rating Scale [IRS]). 

Æ Acceptability of treatment. 

• Final outcomes: 

Æ 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). 


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42468 Federal Register / Vol. 87, No. 135 / Friday, July 15, 2022 / Notices 

PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)—Continued 

PICOTS element Inclusion criteria Exclusion criteria 

Æ 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, courtmandated interventions, need for residential placement). 

Æ Obesity, tobacco use, substance abuse, mood disorders, depression or anxiety, self-injurious non-suicidal behavior, suicide (attempted or completed), suicidal ideation, mortality. 

Æ 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. 

Æ Overtreatment, diversion and misuse of 

pharmacotherapy, parental stress, time demands/opportunity cost. 

KQ 3 (monitoring): 

• Changes in treatment or dose. 

• Adverse effects of treatment. 

• Changes in intermediate and final outcomes. 

Timing .................................. KQ 1 (diagnosis): 

• 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. 

• 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 ........................ • Original data. 

KQ 1–3: Randomized controlled trials (RCTs). 

KQ 1 (diagnosis): For diagnostic accuracy, observational studies, including cross-sectional studies, are 

eligible if they include patients with diagnostic uncertainty and direct comparison of diagnosis in primary 

care to diagnosis by a specialist. 

KQ 1 (diagnosis) and KQ 2 (treatment): controlled clinical trials and prospective and retrospective observational studies with comparator; sample size: 

• ≥20 participants. 

• ≥100 participants for studies comparing two or more 

pharmacologic treatments. 

KQ 3 (monitoring): no study size restriction. 

Editorials, nonsystematic reviews, letters, case series, 

case reports, abstract-only, pre-post studies. Because studies with fewer than 20 subjects are often 

pilot studies or studies of lower quality, these are excluded. Given the research volume on pharmacologic 

treatment the sample size limit for non-RCTs is 100 

participants, representing population study sizes that 

could substantially impact the assessment of the existing evidence base. Systematic reviews are not eligible for inclusion but will be retained. 

Other limiters ........................ • English-language publications. 

• 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. 

Non-English language and abbreviated publications 

(abstracts, letters). 

• KQ 3: Monitoring strategies and long-term effects 

have no publication year restriction. 

• 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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