Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Notices 2611 

INCLUSION AND EXCLUSION CRITERIA BY POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING/STUDY

DESIGN (PICOTS)—Continued 

PICOTS 

elements Inclusion criteria Exclusion criteria 

Timing ............... • Type 2 diabetes ................................................ • Any intervention length <12 weeks. 

• Minimum intervention length of 12 weeks Effect on growth, size, and body composition.

Æ Minimum intervention length of 12 weeks.

Settings ............. • All except hospital and acute care .................... • Hospital and acute care. 

Study design ..... • Randomized controlled trials .............................

• Nonrandomized controlled trials, including 

quasi-experimental and controlled before-andafter studies.

• Prospective cohort studies ................................

• Nested case-control studies ..............................

• Relevant systematic reviews, or meta-analyses 

(used for identifying additional studies).

• In vitro studies, nonoriginal data (e.g., narrative reviews, scoping reviews, editorials, letters, or erratum), retrospective cohort studies, case 

series, qualitative studies, cost-benefit analysis, cross-sectional (i.e., 

nonlongitudinal) studies, survey. 

Publications ....... • Studies published in English only .....................

• Studies published in peer-reviewed journals ....

• Studies published at and after the year 2000 ..

• Non-English language studies. 

Abbreviations: BMI = body mass index; HbA1c = hemoglobin A1C; GI = gastrointestinal; KQ = Key Question; PICOTS = populations, interventions, comparators, outcomes, timing, and settings; RCT = randomized controlled trial; U.S. = United States 

Dated: January 8, 2024. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2024–00618 Filed 1–12–24; 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 Updating the Measurement 

Criteria for AHRQ’s National 

Healthcare Quality and Disparities 

Report (NHQDR) 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. ACTION: 

Request for Supplemental Evidence and 

Data Submission. 

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 

Updating the Measurement Criteria for 

AHRQ’s National Healthcare Quality 

and Disparities Report (NHQDR), 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 February 15, 2024. 

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: 

Kelly Carper, Telephone: 301–427–1656 

or Email: epc@ahrq.hhs.gov. 

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 Updating the Measurement 

Criteria for AHRQ’s National Healthcare 

Quality and Disparities Report 

(NHQDR). AHRQ is conducting this 

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 Updating the 

Measurement Criteria for AHRQ’s 

National Healthcare Quality and 

Disparities Report (NHQDR). The entire 

research protocol is available online at: 

https://effectivehealthcare.ahrq.gov/ 

products/measurement-criteria-qdr/ 

protocol. 

This is to notify the public that the 

EPC Program would find the following 

information on Updating the 

Measurement Criteria for AHRQ’s 

National Healthcare Quality and 

Disparities Report (NHQDR) helpful: 

D A list of completed studies that 

your organization has sponsored for this 

topic. 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, if relevant: 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 

topic. In the list, please provide the 

ClinicalTrials.gov trial number or, if the 

trial is not registered, the protocol for 

the study including, if relevant, 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 topic and an index 

outlining the relevant information in 

each submitted file. 

Your contribution is very beneficial to 

the Program. Materials submitted must 


ddrumheller on DSK120RN23PROD with NOTICES1
2612 Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Notices 

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 topics 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 review will answer the following 

questions. This information is provided 

as background. AHRQ is not requesting 

that the public provide answers to these 

questions. 

Guiding Questions 

The brief will be facilitated by guiding 

questions (GQs), documenting research 

and key informant input: 

GQ1. Which prioritization criteria for 

health care quality measures have been 

proposed? 

• What settings and intended use 

were the criteria developed for? 

• How are the criteria defined and 

operationalized? 

• In what context have these criteria 

been used? 

• How are the criteria similar or 

different from the current NHQDR 

criteria? 

GQ2. How should the current NHQDR 

measure selection prioritization criteria 

be updated? 

• What is the operationalized 

definition of each updated prioritization 

criteria? 

• What type of health care quality 

measures would help the NHQDR’s 

primary audience monitor the 

effectiveness of health policy levers? 

GQ3. How should the new NHDQR 

measure selection prioritization criteria 

be applied? 

PICOTS (Populations, Interventions, 

Comparators, Outcomes, Timing, and 

Setting) 

CRITERIA FOR INCLUSION/EXCLUSION OF STUDIES IN THE REVIEW

Domain Inclusion Exclusion 

Population ............ • Publications that address quality of care indicators, criteria, or benchmarks. We will accept the authors’ definition 

of quality of care. Quality indicators may include care 

processes-related measures (e.g., follow-up post discharge, continuity of care, medication errors), heath services utilization measures (e.g., hospital readmission, 

emergency department visit), care satisfaction (e.g., patient satisfaction, care needs met, trust in care provider), 

or health outcomes (e.g., mortality, physical functional status, mental functioning, quality of life) used as quality indicators; care disparities may either address differences in 

provided health services, focus on care services or health 

outcomes of priority populations.

• Publications not addressing quality of care, disparities, or 

social determinants of health. 

Concept ................ • Publications that describe a process of developing, selecting, applying, comparing, evaluating, or prioritizing measures, i.e., procedures, guiding principles, suggested selection criteria, proposed decision rules, or consensus finding 

methods; publications must describe an empirical ongoing 

or completed process to select measures used to assess 

care quality of a healthcare delivery organization or 

healthcare system.

• Publications describing only the need for quality of care 

measures, only quality of care measures without describing the process of how to select measures, only discussing the importance of selecting measures, suggesting 

measures only for individual clinical areas or patient populations, or only describing hypothetical steps to select 

measures. 

Context ................. • Healthcare, specifically healthcare delivery organizations .. • Studies in contexts outside of healthcare, not specific to 

healthcare, or not applicable to the U.S. health care system. 

Other limiters ....... • Reports published in English-language journal manuscripts, trial records, and gray literature in the public domain from the outlined sources.• Data reported in abbreviated format (e.g., conference abstracts) will be excluded; studies not published in English. 

• Systematic reviews will be retained for reference mining. 

Searches will be conducted without 

date restriction. 

Dated: January 8, 2024. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2024–00617 Filed 1–12–24; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–24–0621] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

In accordance with the Paperwork 

Reduction Act of 1995, the Centers for 

Disease Control and Prevention (CDC) 

has submitted the information 

collection request titled ‘‘National 

Youth Tobacco Survey 2024–2026’’ to 

the Office of Management and Budget 

(OMB) for review and approval. CDC 

previously published a ‘‘Proposed Data 

Collection Submitted for Public 

Comment and Recommendations’’ 

notice on June 5, 2023 to obtain 

comments from the public and affected 

agencies. CDC received five comments 

related to the previous notice. This 

notice serves to allow an additional 30 

days for public and affected agency 

comments. 

CDC will accept all comments for this 

proposed information collection project. 

The Office of Management and Budget 

is particularly interested in comments 

that: 

(a) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 


ddrumheller on DSK120RN23PROD with NOTICES1