Notice2024-17935
Supplemental Evidence and Data Request on Environmental, Clinical and Economic Outcomes of Hospital Resources To Prevent Hospital-Acquired Infections
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
August 13, 2024
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 Environmental, Clinical and Economic Outcomes of Hospital Resources to Prevent Hospital-Acquired Infections, 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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 89 Issue 156 (Tuesday, August 13, 2024)</title>
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[Federal Register Volume 89, Number 156 (Tuesday, August 13, 2024)]
[Notices]
[Pages 65911-65912]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-17935]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Environmental, Clinical
and Economic Outcomes of Hospital Resources To Prevent Hospital-
Acquired Infections
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 Environmental,
Clinical and Economic Outcomes of Hospital Resources to Prevent
Hospital-Acquired Infections, 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published and unpublished pertinent scientific information will improve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 September 12, 2024.
ADDRESSES:
Email submissions: <a href="/cdn-cgi/l/email-protection#4227322102232a30336c2a2a316c252d34"><span class="__cf_email__" data-cfemail="5134213211303923207f3939227f363e27">[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#fc998c9fbc9d948e8dd294948fd29b938a"><span class="__cf_email__" data-cfemail="4c293c2f0c2d243e3d6224243f622b233a">[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 Environmental,
Clinical and Economic Outcomes of Hospital Resources to Prevent
Hospital-Acquired Infections. 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 Environmental, Clinical and Economic Outcomes of
Hospital Resources to Prevent Hospital-Acquired Infections. The entire
research protocol is available online at: <a href="https://effectivehealthcare.ahrq.gov/products/prevent-hai/protocol">https://effectivehealthcare.ahrq.gov/products/prevent-hai/protocol</a>.
This is to notify the public that the EPC Program would find the
following information on Environmental, Clinical and Economic Outcomes
of Hospital Resources to Prevent Hospital-Acquired Infections 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 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://effectivehealthcare.ahrq.gov/email-updates">https://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 (GQ)
GQ 1. What healthcare research examines the health, economic, and
environmental outcomes of reprocessed reusable devices and items or
reprocessed single-use devices and items compared with non-reprocessed
single-use devices and items in hospital settings?
GQ 2. What are key evidence gaps and opportunities for future
research?
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PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and
Setting) Inclusion and Exclusion Criteria
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Category Inclusion criteria Exclusion criteria
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Population................ Primary: Individuals Individuals receiving
receiving acute ambulatory care.
medical care.
Secondary: Healthcare
workers using or
caring for devices
used in patient care.
Interventions............. Primary interest: Devices/items with
Devices/items that minimal or no
are intended to pathogen
prevent infection or transmission risk.
are used for general Devices/items
bedside care, primarily used in an
including but not ambulatory or non-
limited to PPE, acute-care setting.
drapes, linens, Devices/items that
laryngoscopes, blood have been
pressure cuffs, reprocessed under
pulse oximeters. emergency use
Secondary interest: authorization only.
Other devices/items Implantable devices
used during hospital other than
care, including but catheters.
not limited to:
surgical devices,
other scopes.
Regulatory status:
All devices/items
must be either.
<bullet> FDA
approved as
reusable, and
reprocessed per
specifications.
OR
<bullet>
Designated as
single-use, FDA
authorized for
reprocessing, and
reprocessed per
specifications.
Comparators............... Devices/items that Single-use devices/
are approved as items for which no
single-use and are reusable or
discarded after one authorized
use. reprocessed
alternatives are
available in the US.
Outcomes.................. Health outcomes Quality of
(Patient-level or reprocessing.
aggregated patient Usability by
data). healthcare workers
Outcomes include but or patients.
are not limited to: Device/item
HAI, SSI, or preferences of
pathogen healthcare workers
transmission or patients.
(including MDRO; Device/item
Sepsis; ICU stay availability.
related to HAI; Bacterial
Length of stay; colonization of
Mortality; Adverse device/item.
effects; Healthcare
worker infection or
injury.
Economic outcomes
(Hospital/health
system perspective).
Outcomes include but
are not limited to:
Procurement cost;
Cost per procedure/
use; Costs for:
reprocessing,
transportation,
storage,
functionality
testing,
maintenance, repair,
disposal,
replacement; Supply
chain implications.
Environmental
outcomes
a. Environmental
impact
(Global, national, or
regional
perspective).
Outcomes include but
are not limited to:
Greenhouse gas
emissions; Air
pollution; Water
use; Water
contamination;
Energy use; Chemical
use and toxicity;
Recycling volume;
Landfill use;
Carcinogenic
exposure; Climate
change; Raw material
extraction and
processing.
b. Environmental
health
(Population health
perspective).
Outcomes include but
are not limited to:
Respiratory illness;
Cardiovascular
disease; Cancer
risk; Infectious
disease outbreaks.
Timing.................... Any.................. NA.
Setting................... Acute care hospitals Non-hospital
in countries rated settings.
``very high'' on the Other countries.
2021 Human
Development Index
(as defined by the
United Nations
Development
Programme) *.
Publication type.......... English language..... Non-English-language,
For primary interest abstracts, case
interventions reports, non-
(devices/items used comparative studies,
to prevent narrative reviews,
infections or for commentaries,
general bedside guidelines.
care): SRs,
randomized
controlled trials,
nonrandomized
controlled studies.
For secondary
interest
interventions (other
devices/items used
for hospital care):
SRs.
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FDA: Food and Drug Administration; HAI: Healthcare-associated infection;
ICU: Intensive care unit; MDRO: Multi-drug resistant organism; NA: Not
applicable; PPE: Personal protective equipment; SR: Systematic review;
SSI: Surgical site infection; US: United States.
* Human development index. United Nations Development Programme.
Accessed April 16, 2024. <a href="https://hdr.undp.org/data-center/human-development-index#/indicies/HDI">https://hdr.undp.org/data-center/human-development-index#/indicies/HDI</a>.
Mamatha Pancholi,
Deputy Director.
[FR Doc. 2024-17935 Filed 8-12-24; 8:45 am]
BILLING CODE 4160-90-P
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