Notice2023-22503
Supplemental Evidence and Data Request on Documentation Burden
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 12, 2023
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 Documentation Burden, 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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 88 Issue 196 (Thursday, October 12, 2023)</title>
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[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Notices]
[Pages 70661-70662]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-22503]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Documentation Burden
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data submission.
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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 Documentation
Burden, 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 Access to published and unpublished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 November 13, 2023.
ADDRESSES:
Email submissions: <a href="/cdn-cgi/l/email-protection#dbbeabb89bbab3a9aaf5b3b3a8f5bcb4ad"><span class="__cf_email__" data-cfemail="7c190c1f3c1d140e0d5214140f521b130a">[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: Kelly Carper, Telephone: 301-427-1656
or Email: <a href="/cdn-cgi/l/email-protection#4d283d2e0d2c253f3c6325253e632a223b"><span class="__cf_email__" data-cfemail="4227322102232a30336c2a2a316c252d34">[email protected]</span></a>.
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 Documentation Burden.
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 Documentation Burden. The entire research protocol is
available online at: <a href="https://effectivehealthcare.ahrq.gov/products/documentation-burden/protocol">https://effectivehealthcare.ahrq.gov/products/documentation-burden/protocol</a>.
This is to notify the public that the EPC Program would find the
following information on Documentation Burden helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this topic. 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, 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.
[ssquf] A list of ongoing studies that your organization has
sponsored for this topic. 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, 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.
[ssquf] Description of whether the above studies constitute ALL
Phase II and above clinical trials sponsored by your organization for
this topic and an index
[[Page 70662]]
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 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: <a href="https://www.effectivehealthcare.ahrq.gov/email-updates">https://www.effectivehealthcare.ahrq.gov/email-updates</a>.
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
Description/Overview of Measurements of Documentation Burden
(1) What metrics of documentation burden that have been developed
or used (including metrics broadly--quantitative and qualitative)?
(a) For which settings, populations, and intended uses were the
metrics developed?
(b) How have these metrics been applied?
(c) Is there published information available on validity of the
metrics?
(d) What are the key strengths and weaknesses of different metrics
that have been used?
(2) What are the different perspectives on the appropriateness of
different metrics of documentation burden that have been applied/
proposed (e.g., scalability, resource intensiveness to collect,
equitable across populations)?
(3) What are the perceptions of documentation burden from the
perspective of people in different clinical roles (e.g., doctor, nurse,
etc.) and patients/caregivers?
Factors Influencing Documentation Burden
(4) What is the role of patients in documentation burden?
(5) What is the role of setting (i.e., rural vs. urban, hospital,
outpatient, academic institution, etc.) in documentation burden?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and
Settings)
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Exclusion
PICOTS elements Inclusion criteria criteria
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Population.................... Healthcare <bullet> Any
professionals, healthcare
including but not professional
limited to:. without direct
<bullet> Physicians... patient
<bullet> Nurses....... contact.
<bullet> Other
professionals..
Interventions (Exposure)...... <bullet> EHR.......... <bullet> None.
<bullet> Electronic
prescribing..
<bullet> Electronic
patient portals..
<bullet> Computerized
physician order
entry..
Comparators................... <bullet> None......... <bullet> None.
Outcomes...................... Metrics of <bullet> None.
documentation burden,
including but not
limited to:.
<bullet> WOW..........
<bullet> Time on
Inbox..
<bullet> Time on
Encounter Note
Documentation..
<bullet> Excessive
workload..
<bullet> Time on EHR.
<bullet>
Administrative tasks..
<bullet> Fragmentation
of workflow..
<bullet> Physician-
patient interaction..
Timing........................ <bullet> All.......... <bullet> None.
Settings...................... <bullet> Any clinical <bullet> None.
settings.
Study design.................. <bullet> RCTs......... <bullet> In
<bullet> Comparative vitro studies.
observational <bullet>
studies.. Erratum.
<bullet> Surveys...... <bullet>
<bullet> Qualitative Editorials.
studies.. <bullet>
<bullet> Mixed-method Letters.
studies.. <bullet> Case
<bullet> Systematic studies/case
review or meta- reports.
analysis.. <bullet>
Narrative
reviews.
Publications.................. <bullet> Studies <bullet> Foreign
published in English language
as peer reviewed full- studies.
text articles. ................
<bullet> Published <bullet>
after the year 2000. Conference
abstracts.
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Abbreviations: EHR = electronic health record; RCT = randomized clinical
trials; WOW = Work Outside of Work.
Dated: October 5, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023-22503 Filed 10-11-23; 8:45 am]
BILLING CODE 4160-90-P
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