83 FR 8674 - Request for Information Regarding Patient-Reported Outcome Measures
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality Federal Register Volume 83, Issue 40 (February 28, 2018)
Agency for Healthcare Research and Quality
Federal Register Volume 83, Issue 40 (February 28, 2018)
| Page Range | 8674-8675 | |
| FR Document | 2018-04050 |
[Federal Register Volume 83, Number 40 (Wednesday, February 28, 2018)] [Notices] [Pages 8674-8675] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-04050] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Request for Information Regarding Patient-Reported Outcome Measures AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for information. ----------------------------------------------------------------------- SUMMARY: AHRQ is seeking information submissions from the public. Information is being solicited to inform our work on patient-reported outcomes (PROs). Access to information regarding physical function PRO measure use will assist the selection of measures for AHRQ's efforts to develop and implement user-friendly technical tools to collect and integrate PRO data in electronic health records or other health information technology products. DATES: Submission must be received by April 1, 2018. ADDRESSES: Electronic responses are preferred and should be addressed to [email protected]. Non-electronic responses will also be accepted. Please mail to: Janey Hsiao, Agency for Healthcare Research and Quality, 5600 Fishers Lane, Rockville, MD 20857, Mailstop: 06E73A. FOR FURTHER INFORMATION CONTACT: Janey Hsiao, Health Scientist Administrator, Center for Evidence and Practice Improvement, [email protected], (301) 427-1335. SUPPLEMENTARY INFORMATION: AHRQ plans to conduct a Challenge Competition in Fall 2018 to develop user-friendly technical tools to collect and integrate patient-reported outcome (PRO) data in electronic health records or other health information technology products. The technical tools will be intended for use in ambulatory care settings including primary care and specialty care. For this competition, AHRQ will choose a physical function PRO measure as a use case for the tool development. More information about the Challenge Competition is available at https://www.thefederalregister.org/fdsys/pkg/FR-2017-12-26/pdf/2017-27663.pdf. AHRQ will also conduct another project to pilot test whether the specified standards used in the Challenge Competition can be adapted for data collection utilizing other PRO measures or domains. AHRQ is interested in learning what physical function PRO measures are being used, and about experiences with these measures in clinical practice. We are also interested in methods used to collect these PROs, including computer adaptive testing [[Page 8675]] (CAT). The information will inform AHRQ's decision in selecting physical function PRO measures for the Challenge Competition and the subsequent pilot test. Your contribution will be very beneficial to AHRQ's PRO projects. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter. This RFI is for planning purposes only and should not be construed as a policy, solicitation for applications, or as an obligation on the part of the Government to provide support for any ideas identified in response to it. AHRQ will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder's submission. However, responses to the RFI may be reflected in future solicitation(s) or policies. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). The contents of all submissions will be made available to the public upon request. Materials submitted must be publicly available or able to be made public. Submission Instructions Specific questions of interest to AHRQ include, but are not limited to: 1. What physical function PRO measures does your health system/ practice currently use to collect PRO data? Which PRO measures in use do you find most useful with respect to clinical management, quality improvement, population health, or for other uses? 2. What is the type of care setting (primary care or specialty care) within which these physical function PRO data are collected? Are similar measures used in other settings (e.g., acute care, post-acute care, rehabilitation, home care, long term care)? 3. How are the PRO data collected? Is the PRO data collection via paper or an electronic mechanism? Please specify the electronic mechanism (e.g., patient portal, tablet) and whether the electronic mechanism is internal or external to an electronic health records system. Is CAT used? What is the typical workflow for collecting PRO data? 4. How are the PRO data used (e.g., patient assessment, shared decision making, quality improvement, research?) What has been your experience with the use of these measures? AHRQ is interested in all of the questions listed above, but respondents are welcome to address as many or as few as they choose and to address additional areas of interest not listed. Submission of copies of existing documentation or reports describing the measure and its properties, existing data sources, etc., is highly desirable but not required. Gopal Khanna, Director. [FR Doc. 2018-04050 Filed 2-27-18; 8:45 am] BILLING CODE 4160-90-P
![8674 Federal Register / Vol. 83, No. 40 / Wednesday, February 28, 2018 / Notices
or benefits of any product are field to assess the reliability of the DEPARTMENT OF HEALTH AND
scientifically or clinically proven or results. HUMAN SERVICES
about the existence, contents, validity, Provision X mandates that
results, conclusions, or interpretations respondents acknowledge receipt of the Agency for Healthcare Research and
of any test, study, or research. order, distribute the order to principals, Quality
Provision IV is a provision for FDA- officers, and certain employees and
approved claims. agents, and obtain signed Request for Information Regarding
Provision V prohibits acknowledgments from them. Patient-Reported Outcome Measures
misrepresentations in connection with Provision XI requires that respondents AGENCY: Agency for Healthcare Research
the marketing, advertising, or promoting submit compliance reports to the FTC and Quality (AHRQ), HHS.
of any product, service, or program that 60 days after the order’s issuance and ACTION: Request for information.
paid commercial advertising is submit notifications when certain
independent programming. events occur for 10 years. SUMMARY: AHRQ is seeking information
Provision VI prohibits any submissions from the public.
Provision XII requires that
representation about any user, Information is being solicited to inform
consumer, or endorser of a covered respondents create and retain certain
records for 10 years. our work on patient-reported outcomes
product without disclosing, clearly and (PROs). Access to information regarding
conspicuously, and in close proximity Provision XIII provides for the FTC’s
continued compliance monitoring of physical function PRO measure use will
to that representation, any unexpected assist the selection of measures for
material connection between such respondents’ activities during the
order’s effective dates. AHRQ’s efforts to develop and
endorser and (1) any respondent; or (2) implement user-friendly technical tools
any other individual or entity affiliated Provision XIV requires that
to collect and integrate PRO data in
with the product. ‘‘Unexpected material respondents notify their licensees,
electronic health records or other health
connection’’ means any relationship monitor their highest-selling licensees’
information technology products.
that might materially affect the weight advertising to ensure compliance with
DATES: Submission must be received by
or credibility of the testimonial or Provisions I through III, and suspend
any licensee who makes any prohibited April 1, 2018.
endorsement and that would not
claims. Respondents must terminate any ADDRESSES: Electronic responses are
reasonably be expected by consumers.
Provision VII prohibits licensee who continues to make preferred and should be addressed to
misrepresentations regarding the status prohibited claims. There are two limited Janey.hsiao@ahrq.hhs.gov. Non-
of any endorser or person providing a exceptions to the monitoring electronic responses will also be
review of a product, including a requirement: (1) Representations during accepted. Please mail to: Janey Hsiao,
misrepresentation that the endorser or private consultations between a licensee Agency for Healthcare Research and
reviewer is an independent or ordinary and one of the licensee’s patients about Quality, 5600 Fishers Lane, Rockville,
user of the product. the potential safety, health benefits, MD 20857, Mailstop: 06E73A.
Provision VIII prohibits respondents performance, efficacy, or side effects of FOR FURTHER INFORMATION CONTACT:
from providing the means and a covered product; and (2) Janey Hsiao, Health Scientist
instrumentalities to make any false or representations about the potential Administrator, Center for Evidence and
misleading statement of material fact, safety, health benefits, performance, Practice Improvement, Janey.hsiao@
including the representations prohibited efficacy, or side effects of a covered ahrq.hhs.gov, (301) 427–1335.
by Provisions I to III. ‘‘Means and product by a licensee who has SUPPLEMENTARY INFORMATION: AHRQ
instrumentalities’’ mean any purchased a covered product solely for plans to conduct a Challenge
information, document, or article incorporation into the licensee’s own Competition in Fall 2018 to develop
referring or relating to any covered product and markets that product user-friendly technical tools to collect
product, including any advertising, without any involvement by and integrate patient-reported outcome
labeling, promotional, or purported respondents. (PRO) data in electronic health records
substantiation materials, for use by a Provision XV requires that or other health information technology
licensee to market or sell any covered respondents send a notice to all products. The technical tools will be
product. customers who purchased directly from intended for use in ambulatory care
Provision IX, triggered when the them TA–65MD or TA–65 Skin within settings including primary care and
human clinical testing requirement in one year prior to the issuance of the specialty care. For this competition,
Provisions I or II applies, requires that order or through a currently active AHRQ will choose a physical function
respondents secure and preserve all enrollment in a continuity or autoship PRO measure as a use case for the tool
underlying or supporting data and program. development. More information about
documents generally accepted by Provision XVI provides that, with the Challenge Competition is available
experts in the field as relevant to an exceptions, the order will terminate in at https://www.gpo.gov/fdsys/pkg/FR-
assessment of the test, such as protocols, 20 years. 2017-12-26/pdf/2017-27663.pdf. AHRQ
instructions, participant-specific data, The purpose of this analysis is to will also conduct another project to
statistical analyses, and contracts with facilitate public comment on the order, pilot test whether the specified
the test’s researchers. There is an and it is not intended to constitute an standards used in the Challenge
exception for a reliably reported test official interpretation of the complaint Competition can be adapted for data
(defined as a test that is published in a collection utilizing other PRO measures
sradovich on DSK3GMQ082PROD with NOTICES
or order, or to modify the order’s terms
peer-reviewed journal) that was not in any way. or domains. AHRQ is interested in
conducted, controlled, or sponsored by, learning what physical function PRO
with, or on behalf of any respondent or By direction of the Commission. measures are being used, and about
by any supplier or manufacturer of the Donald S. Clark, experiences with these measures in
product. Also, the published report Secretary. clinical practice. We are also interested
must provide sufficient information [FR Doc. 2018–04025 Filed 2–27–18; 8:45 am] in methods used to collect these PROs,
about the test for experts in the relevant BILLING CODE 6750–01–P including computer adaptive testing
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![Federal Register / Vol. 83, No. 40 / Wednesday, February 28, 2018 / Notices 8675
(CAT). The information will inform making, quality improvement, include financial holdings,
AHRQ’s decision in selecting physical research?) What has been your consultancies, non-financial scientific
function PRO measures for the experience with the use of these interests, and research grants or
Challenge Competition and the measures? contracts.
subsequent pilot test. AHRQ is interested in all of the To obtain a diversity of perspectives,
Your contribution will be very questions listed above, but respondents AHRQ particularly encourages
beneficial to AHRQ’s PRO projects. This are welcome to address as many or as nominations of women, members of
is a voluntary request for information, few as they choose and to address minority populations, and persons with
and all costs for complying with this additional areas of interest not listed. disabilities. Interested individuals can
request must be borne by the submitter. Submission of copies of existing nominate themselves. Organizations and
This RFI is for planning purposes documentation or reports describing the individuals may nominate one or more
only and should not be construed as a measure and its properties, existing data people qualified for membership on the
policy, solicitation for applications, or sources, etc., is highly desirable but not USPSTF at any time. Individuals
as an obligation on the part of the required. nominated prior to May 15, 2017, who
Government to provide support for any continue to have interest in serving on
ideas identified in response to it. AHRQ Gopal Khanna,
the USPSTF should be re-nominated.
will use the information submitted in Director.
response to this RFI at its discretion and [FR Doc. 2018–04050 Filed 2–27–18; 8:45 am] Qualification Requirements
will not provide comments to any BILLING CODE 4160–90–P To qualify for the USPSTF and
responder’s submission. However, support its mission, an applicant or
responses to the RFI may be reflected in nominee should, at a minimum,
future solicitation(s) or policies. DEPARTMENT OF HEALTH AND demonstrate knowledge, expertise and
Respondents are advised that the HUMAN SERVICES national leadership in the following
Government is under no obligation to areas:
acknowledge receipt of the information Agency for Healthcare Research and
1. The critical evaluation of research
received or provide feedback to Quality
published in peer-reviewed literature
respondents with respect to any Solicitation for Nominations for and in the methods of evidence review;
information submitted. No proprietary, Members of the U.S. Preventive 2. Clinical prevention, health
classified, confidential, or sensitive Services Task Force (USPSTF) promotion and primary health care; and
information should be included in your 3. Implementation of evidence-based
response. The Government reserves the AGENCY: Agency for Healthcare Research recommendations in clinical practice
right to use any non-proprietary and Quality (AHRQ), HHS. including at the clinician-patient level,
technical information in any resultant ACTION: Solicits nominations for new practice level, and health-system level.
solicitation(s). The contents of all members of the USPSTF. Additionally, the Task Force benefits
submissions will be made available to from members with expertise in the
the public upon request. Materials SUMMARY: The Agency for Healthcare following areas:
submitted must be publicly available or Research and Quality (AHRQ) invites
D Public health
able to be made public. nominations of individuals qualified to
D Health equity and the reduction of
serve as members of the U.S. Preventive
Submission Instructions health disparities
Services Task Force (USPSTF).
D Application of science to health
Specific questions of interest to DATES: All nominations submitted in policy
AHRQ include, but are not limited to: writing or electronically will be D Behavioral medicine
1. What physical function PRO considered for appointment to the D Communication of scientific findings
measures does your health system/ USPSTF. Nominations must be received to multiple audiences including
practice currently use to collect PRO by May 15th of a given year to be health care professionals, policy
data? Which PRO measures in use do considered for appointment to begin in makers and the general public.
you find most useful with respect to January 2019.
clinical management, quality Candidates with experience and skills
improvement, population health, or for Nomination Submissions in any of these areas should highlight
other uses? Nominations may be submitted in them in their nomination materials.
2. What is the type of care setting writing or electronically, but should Applicants must have no substantial
(primary care or specialty care) within include: conflicts of interest, whether financial,
which these physical function PRO data 1. The applicant’s current curriculum professional, or intellectual, that would
are collected? Are similar measures vitae and contact information, including impair the scientific integrity of the
used in other settings (e.g., acute care, mailing address, email address, and work of the USPSTF and must be
post-acute care, rehabilitation, home telephone number; and willing to complete regular conflict of
care, long term care)? 2. A letter explaining how this interest disclosures.
3. How are the PRO data collected? Is individual meets the qualification Applicants must have the ability to
the PRO data collection via paper or an requirements and how he or she would work collaboratively with a team of
electronic mechanism? Please specify contribute to the USPSTF. The letter diverse professionals who support the
the electronic mechanism (e.g., patient should also attest to the nominee’s mission of the USPSTF. Applicants
must have adequate time to contribute
sradovich on DSK3GMQ082PROD with NOTICES
portal, tablet) and whether the willingness to serve as a member of the
electronic mechanism is internal or USPSTF. substantively to the work products of
external to an electronic health records AHRQ will later ask people under the USPSTF.
system. Is CAT used? What is the serious consideration for USPSTF ADDRESSES: Submit your responses
typical workflow for collecting PRO membership to provide detailed either in writing or electronically to:
data? information that will permit evaluation Lydia Hill, ATTN: USPSTF
4. How are the PRO data used (e.g., of possible significant conflicts of Nominations, Center for Evidence and
patient assessment, shared decision interest. Such information could Practice Improvement, Agency for
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Document Created: 2018-02-28 03:19:42
Document Modified: 2018-02-28 03:19:42
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Request for information. | |
| Dates | Submission must be received by April 1, 2018. | |
| Contact | Janey Hsiao, Health Scientist Administrator, Center for Evidence and Practice Improvement, [email protected], (301) 427-1335. | |
| FR Citation | 83 FR 8674 |
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