[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Notices]
[Pages 70661-70662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22503]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 Access to published and unpublished 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: [email protected].
    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: [email protected].

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: https://effectivehealthcare.ahrq.gov/products/documentation-burden/protocol.
    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 ClinicalTrials.gov along with the ClinicalTrials.gov 
trial number.
    [ssquf] 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.
    [ssquf] 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.
    [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: 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

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)
------------------------------------------------------------------------
                                                            Exclusion
        PICOTS elements           Inclusion criteria        criteria
------------------------------------------------------------------------
Population....................  Healthcare               Any
                                 professionals,          healthcare
                                 including but not       professional
                                 limited to:.            without direct
                                 Physicians...   patient
                                 Nurses.......   contact.
                                 Other
                                 professionals..
Interventions (Exposure)......   EHR..........   None.
                                 Electronic
                                 prescribing..
                                 Electronic
                                 patient portals..
                                 Computerized
                                 physician order
                                 entry..
Comparators...................   None.........   None.
Outcomes......................  Metrics of               None.
                                 documentation burden,
                                 including but not
                                 limited to:.
                                 WOW..........
                                 Time on
                                 Inbox..
                                 Time on
                                 Encounter Note
                                 Documentation..
                                 Excessive
                                 workload..
                                 Time on EHR.
                                
                                 Administrative tasks..
                                 Fragmentation
                                 of workflow..
                                 Physician-
                                 patient interaction..
Timing........................   All..........   None.
Settings......................   Any clinical    None.
                                 settings.
Study design..................   RCTs.........   In
                                 Comparative     vitro studies.
                                 observational          
                                 studies..               Erratum.
                                 Surveys......  
                                 Qualitative     Editorials.
                                 studies..              
                                 Mixed-method    Letters.
                                 studies..               Case
                                 Systematic      studies/case
                                 review or meta-         reports.
                                 analysis..             
                                                         Narrative
                                                         reviews.
Publications..................   Studies         Foreign
                                 published in English    language
                                 as peer reviewed full-  studies.
                                 text articles.         ................
                                 Published      
                                 after the year 2000.    Conference
                                                         abstracts.
------------------------------------------------------------------------
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