83 FR 49386 - Supplemental Evidence and Data Request on Antipsychotics for the Prevention and Treatment of Delirium: A Systematic Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality Federal Register Volume 83, Issue 190 (October 1, 2018)
Agency for Healthcare Research and Quality
Federal Register Volume 83, Issue 190 (October 1, 2018)
| Page Range | 49386-49388 | |
| FR Document | 2018-21242 |
[Federal Register Volume 83, Number 190 (Monday, October 1, 2018)] [Notices] [Pages 49386-49388] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-21242] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Supplemental Evidence and Data Request on Antipsychotics for the Prevention and Treatment of Delirium: A Systematic Review AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for Supplemental Evidence and Data Submissions ----------------------------------------------------------------------- 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 of Antipsychotics for the Prevention and Treatment of Delirium: A Systematic Review, 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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 October 31, 2018. 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: Jenae Benns, Telephone: 301-427-1496 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 Antipsychotics for the Prevention and Treatment of Delirium: A Systematic Review. AHRQ is conducting this systematic review pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a). 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 [[Page 49387]] literature by requesting information from the public (e.g., details of studies conducted). We are looking for studies that report on Antipsychotics for the Prevention and Treatment of Delirium: A Systematic Review, including those that describe adverse events. The entire research protocol, including the key questions, is also available online at: https://effectivehealthcare.ahrq.gov/topics/antipsychotics/research-protocol. This is to notify the public that the EPC Program would find the following information on Antipsychotics for the Prevention and Treatment of Delirium: A Systematic Review helpful: [ssquf] A list of completed studies that your organization has sponsored for this indication. 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, please provide a summary, including the following elements: 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 indication. In the list, please provide the ClinicalTrials.gov trial number or, if the trial is not registered, the protocol for the study including 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 indication and an index outlining the relevant information in each submitted file. Your contribution will be very beneficial to the EPC 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 indications 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 systematic review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions. The Key Questions I. What are the benefits and harms for antipsychotics compared to each other, placebo, or non-drug approaches to prevent delirium? A. What are the benefits and harms for antipsychotics compared to each other, placebo, or non-drug approaches to prevent delirium in persons aged 65 years or older? B. What are the benefits and harms for antipsychotics compared to each other, placebo, or non-drug approaches to prevent delirium in persons with dementia? C. What are the benefits and harms for antipsychotics compared to each other, placebo, or non-drug approaches to prevent delirium in patients in an intensive care unit? D. What are the benefits and harms for antipsychotics compared to each other, placebo, or non-drug approaches to prevent delirium in patients in a post-acute care facility? E. What are the benefits and harms for antipsychotics compared to each other, placebo, or non-drug approaches to prevent delirium in patients in palliative or hospice care? F. What are the benefits and harms for antipsychotics compared to each other, placebo, or non-drug approaches to prevent delirium in patients in post-operative care? II. What are the benefits and harms for antipsychotics compared to each other, placebo, or non-drug approaches to treat delirium? A. What are the benefits and harms for antipsychotics compared to each other, placebo, or non-drug approaches to treat delirium in persons aged 65 years or older? B. What are the benefits and harms for antipsychotics compared to each other, placebo, or non-drug approaches to treat delirium in persons with dementia? C. What are the benefits and harms for antipsychotics compared to each other, placebo, or non-drug approaches to treat delirium in patients in an intensive care unit? D. What are the benefits and harms for antipsychotics compared to each other, placebo, or non-drug approaches to treat delirium in patients in a post-acute care facility? E. What are the benefits and harms for antipsychotics compared to each other, placebo, or non-drug approaches to treat delirium in patients in palliative or hospice care? F. What are the benefits and harms for antipsychotics compared to each other, placebo, or non-drug approaches to treat delirium in patients in post-operative care? PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, Settings) Population(s): I. KQ 1: Hospitalized adults, adults in post-acute care, adults in palliative or hospice care, or adults in post-operative care II. KQ 2: Hospitalized adults, adults in post-acute care, adults in palliative or hospice care, or adults in post-operative care who have been diagnosed with delirium using a validated instrument Interventions: I. Antipsychotic drugs, including A. Any first-generation agent (chlorpromazine, droperidol, fluphenazine, haloperidol, loxapine, molindone, perphenazine, pimozide, prochlorperazine, thiothixene, thioridazine, trifluoperazine) B. Any second-generation agent (aripiprazole, asenapine, brexpiprazole, cariprazine, clozapine, iloperidone, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone) II. We will only include studies where the effects of the antipsychotic drugs can be isolated. Comparators I. KQ 1: Non-drug approaches to preventing delirium, placebo, active control, usual care II. KQ 2: Non-drug approaches to treating delirium, placebo, active control, usual care Outcomes: I. Intermediate outcomes A. Short-term delirium symptoms B. Delirium severity C. Delirium-free, coma-free days alive D. Duration of delirium E. Patient distress F. Use of rescue therapy G. Use of physical restraint II. Final health or patient-centered outcomes A. Mortality B. Quality of life C. Cognitive and emotional functioning (includes functioning related to memory, communication, concentration, and understanding [[Page 49388]] instructions) D. Long-term cognitive impairment (Change in cognition after delirium that has a long-term duration or is possibly permanent) E. Institutionalization (living in an assisted living facility or nursing home) F. Caregiver burden/strain G. Falls H. Memory of patient distress III. Resource utilization A. Re-admissions to hospital or ICU B. Length of stay in ICU C. Length of stay in hospital D. Length of stay in skilled nursing facility E. Sitter use F. Hospice enrollment IV. Adverse effects of intervention(s) A. Sedation B. Weight gain C. Changes in appetite D. Cardiac effects E. Neurologic effects F. Paradoxical reactions G. Hypersensitivity reactions H. Inappropriate continuation of antipsychotic medication I. Swallowing difficulties J. Aspiration pneumonia III. Timing A. Any duration of follow-up IV. Settings A. Hospital setting B. Post-acute care setting C. Palliative care setting Francis D. Chesley, Jr., Deputy Director. [FR Doc. 2018-21242 Filed 9-28-18; 8:45 am] BILLING CODE 4160-90-P
![49386 Federal Register / Vol. 83, No. 190 / Monday, October 1, 2018 / Notices
instructions to reflect the changes to the are required to report certain assets, DEPARTMENT OF HEALTH AND
financial disclosure regulation. suggesting that the form requires HUMAN SERVICES
Specifically, OGE proposes to: Revise excessive reporting of ‘‘low value’’ data.
the reporting period for termination As discussed above, the financial Agency for Healthcare Research and
reports to include the entire preceding disclosure requirements are dictated by Quality
calendar year if a required annual report the EIGA. Therefore, OGE cannot make
has not been filed; revise the income substantive changes to the financial Supplemental Evidence and Data
disclosure requirement to include only disclosure reporting requirements Request on Antipsychotics for the
received income; revise the ‘‘widely Prevention and Treatment of Delirium:
through a modification of the OGE Form
diversified’’ criterion for purposes of A Systematic Review
278e.
determining whether a fund qualifies as AGENCY: Agency for Healthcare Research
an ‘‘excepted investment fund;’’ add a Finally, the third commenter also
stated that the government’s estimate of and Quality (AHRQ), HHS.
new feature (checkbox) for purposes of
the reporting burden vastly understates ACTION: Request for Supplemental
managing early termination report filing
on the Integrity version of the Form the actual burden for candidates with Evidence and Data Submissions
278e; clarify the Definition section of extensive or complicated financial
holdings. In addressing this issue, the SUMMARY: The Agency for Healthcare
Part 2; clarify when a source of Research and Quality (AHRQ) is seeking
compensation need not be disclosed and commenter noted that completing the
scientific information submissions from
the method for disclosing the existence form required ‘‘at least 40 hours of
the public. Scientific information is
of such sources; and eliminate the work’’ by him and his family. He also
being solicited to inform our review of
disclosure of transactions that occurred noted that the government’s cumulative
Antipsychotics for the Prevention and
before the reporting individual became response time during the review and
Treatment of Delirium: A Systematic
subject to the public financial disclosure certification process was 114 days. As
Review, which is currently being
requirements. an initial matter, OGE notes that its
conducted by the AHRQ’s Evidence-
OGE is also proposing to update the estimate of the average reporting burden
based Practice Centers (EPC) Program.
Privacy Act statement in accordance for the 278e is currently ten hours, not
Access to published and unpublished
with changes to the applicable system of three as stated by the commenter.
pertinent scientific information will
records and to make certain minor Moreover, the estimated burden improve the quality of this review.
formatting changes and corrections to properly does not include the time
the instructions and one of the data DATES: Submission Deadline on or
spent by the government in reviewing
entry fields. and responding to the filers’ completed before October 31, 2018.
OGE published a first round notice of forms. OGE’s estimated time per ADDRESSES:
its intent to request paperwork response is an average based on the Email submissions: epc@
clearance for a modified OGE Form 278e estimated burden on all types of filers— ahrq.hhs.gov.
Executive Branch Personnel Public those with complicated financial Print submissions:
Financial Disclosure Report. See 83 FR holdings and those with simpler Mailing Address: Center for Evidence
32122 (July 11, 2018). OGE received financial holdings. While OGE and Practice Improvement, Agency for
three responses to that notice. The first recognizes that the burden for a filer Healthcare Research and Quality,
response was unrelated to the notice with extensive or complicated financial ATTN: EPC SEADs Coordinator, 5600
and did not address the information holdings may be significantly more than Fishers Lane, Mail Stop 06E53A,
collection. ten hours, the estimated burden for the Rockville, MD 20857.
The second comment suggested Shipping Address (FedEx, UPS, etc.):
majority of filers is fewer than five
eliminating the requirement to report Center for Evidence and Practice
hours. Accordingly, OGE declines to
diversified mutual funds. The financial Improvement, Agency for Healthcare
revise its estimated burden at this time.
disclosure requirements are dictated by Research and Quality, ATTN: EPC
the Ethics in Government Act (EIGA), 5 Request for Comments: Agency and
SEADs Coordinator, 5600 Fishers Lane,
U.S.C. app. sec. 102, as amended. The public comment is again invited Mail Stop 06E77D, Rockville, MD
commenter’s suggested change could specifically on the need for and 20857.
not be made without revisions to the practical utility of this information
EIGA. Accordingly, OGE declines to collection, the accuracy of OGE’s FOR FURTHER INFORMATION CONTACT:
adopt this suggestion as a modification burden estimate, the enhancement of Jenae Benns, Telephone: 301–427–1496
of the OGE Form 278e. quality, utility, and clarity of the or Email: epc@ahrq.hhs.gov.
The third comment was from an information collected, and the SUPPLEMENTARY INFORMATION: The
individual identifying himself as a minimization of burden (including the Agency for Healthcare Research and
former nominee to a Presidentially- use of information technology). Quality has commissioned the
appointed, Senate-confirmed position. Comments received in response to this Evidence-based Practice Centers (EPC)
The commenter made several notice may be included with the OGE Program to complete a review of the
suggestions about how the government request for approval of the modified evidence for Antipsychotics for the
should address potential conflicts of information collection. The comments Prevention and Treatment of Delirium:
interest identified through the financial will also become a matter of public A Systematic Review. AHRQ is
disclosure review and certification record. conducting this systematic review
process, as well as ways that the pursuant to Section 902(a) of the Public
Approved: September 26, 2018.
amozie on DSK3GDR082PROD with NOTICES
government could make that process Health Service Act, 42 U.S.C. 299a(a).
more efficient. These matters are beyond Diana Veilleux, The EPC Program is dedicated to
the scope of the information collection Chief, Legal, External Affairs and identifying as many studies as possible
and cannot be addressed through the Performance Branch, Office of Government that are relevant to the questions for
modification of the OGE Form 278e. The Ethics. each of its reviews. In order to do so, we
commenter also made suggestions [FR Doc. 2018–21270 Filed 9–28–18; 8:45 am] are supplementing the usual manual
regarding the detail with which filers BILLING CODE 6345–03–P and electronic database searches of the
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![49388 Federal Register / Vol. 83, No. 190 / Monday, October 1, 2018 / Notices
instructions) Occupational Safety and Health CO.1 Digital Wave Corporation
D. Long-term cognitive impairment (NIOSH), within the Centers for Disease manufactures ultrasonic examination
(Change in cognition after delirium Control and Prevention, about the safety cylinder testing equipment, modal
that has a long-term duration or is of cylinders extended beyond the acoustic emission testing equipment,
possibly permanent) manufacturers’ stated service life. and provides associated inspection
E. Institutionalization (living in an NIOSH is seeking information about the services, including the requalification of
assisted living facility or nursing potential effect of the special permit, as carbon-fiber reinforced aluminum-lined
home) it may relate to the safety of self- cylinders. Pursuant to DOT–SP 16320,
F. Caregiver burden/strain contained breathing apparatus modal acoustic emission requalification
G. Falls respirators approved by NIOSH for use testing allows DOT–CFFC cylinders to
H. Memory of patient distress in U.S. workplaces. be authorized for use for 5 years after
III. Resource utilization the original 15-year service life;
Comments must be received by
DATES:
A. Re-admissions to hospital or ICU cylinders could be requalified three
November 30, 2018. times beyond the original 15-year
B. Length of stay in ICU
C. Length of stay in hospital ADDRESSES: service life, for a total service life of 30
D. Length of stay in skilled nursing Written comments: You may submit years.
facility comments by any of the following Modal acoustic emission testing is an
E. Sitter use methods: advanced, non-destructive evaluation of
F. Hospice enrollment carbon-fiber reinforced aluminum-lined
• Federal eRulemaking Portal: http:// cylinders that detects structural damage
IV. Adverse effects of intervention(s) www.regulations.gov. Follow the
A. Sedation which can compromise burst pressure
instructions for submitting comments to strength in a composite overwrapped
B. Weight gain the docket.
C. Changes in appetite pressure vessel. The modal acoustic
• Mail: NIOSH Docket Office, Robert emission waveforms can be used to
D. Cardiac effects
A. Taft Laboratories, MS–C34, 1090 identify damage such as fiber breakage
E. Neurologic effects
Tusculum Avenue, Cincinnati, OH and delamination. Some stakeholders
F. Paradoxical reactions
45226. have expressed concerns regarding
G. Hypersensitivity reactions
H. Inappropriate continuation of Instructions: All submissions received potential cylinder failure when the
antipsychotic medication must include the agency name (Centers service life is extended past the service
I. Swallowing difficulties for Disease Control and Prevention, life identified on the original special
J. Aspiration pneumonia HHS) and docket number (CDC–2018– permit. Since DOT–SP 16320 was
III. Timing 0093; NIOSH–320) for this action. All issued, more than 3,500 carbon-fiber
A. Any duration of follow-up relevant comments, including any reinforced aluminum-lined cylinders
IV. Settings personal information provided, will be have been requalified beyond their
A. Hospital setting posted without change to http:// original 15-year service life using the
B. Post-acute care setting www.regulations.gov. modal acoustic emission method.
NIOSH has published guidance
C. Palliative care setting FOR FURTHER INFORMATION CONTACT: advising SCBA users who may be
Francis D. Chesley, Jr., Jeffrey Peterson, NIOSH National concerned about using modal acoustic
Deputy Director. Personal Protective Technology emission-requalified cylinders as part of
[FR Doc. 2018–21242 Filed 9–28–18; 8:45 am] Laboratory, 626 Cochrans Mill Road, their NIOSH-approved SCBA
BILLING CODE 4160–90–P
Pittsburgh, PA 15236; 1–888–654–2294 configuration to review the user
(this is a toll-free number); instructions, supplemental
PPEconcerns@cdc.gov. informational inserts, safety
DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: The precautions, and SCBA warranty
HUMAN SERVICES Department of Transportation approves information provided by the NIOSH
certain carbon-fiber reinforced approval holder.2 The guidance further
Centers for Disease Control and aluminum-lined cylinders (hereinafter encourages approval holders to provide
Prevention ‘‘DOT–CFFC’’), which are commonly respiratory protection program
[Docket No. CDC–2018–0093; NIOSH–320] used to provide breathing air in the self- administrators and SCBA users with
contained breathing apparatus (SCBA) current recommendations regarding the
Self-Contained Breathing Apparatus respirators typically carried by DOT–SP 16320 requalification method
Compressed Breathing Gas firefighters and other industrial workers with regard to service life limitations or
Containers; Request for Information to protect them in atmospheres other relevant matters.
immediately dangerous to life and NIOSH seeks to better understand the
AGENCY: Centers for Disease Control and use of modal acoustic emission testing
health. Currently, all DOT–CFFC
Prevention, HHS. to requalify DOT–CFFC cylinders
approved cylinders that are a sub-
ACTION: Request for information. component of NIOSH-approved SCBA beyond the original 15-year service life,
have a service life of 15 years; DOT as permitted by DOT–SP 16320, as well
SUMMARY: In October 2017, the as the safety and health concerns of
Department of Transportation (DOT) regulations require ‘‘requalification’’
every 5 years to ensure that each users in industrial settings, including
issued a special permit to the Digital the fire service and first responders.
cylinder can hold its rated pressure for
amozie on DSK3GDR082PROD with NOTICES
Wave Corporation, allowing the
company to extend the service life of the duration of the 15-year service life. 1 DOT Pipeline and Hazardous Materials Safety
certain carbon-fiber reinforced In October 2017, the DOT Pipeline Administration, DOT–SP 16320, https://
aluminum-lined cylinders. Some and Hazardous Materials Safety www.phmsa.dot.gov/approvals-and-permits/
Administration issued special permit, hazmat/file-serve/offer/SP16320.pdf/offerserver/
stakeholders, including respirator and SP16320.
cylinder manufacturers, have expressed DOT–SP 16320 (Third Revision), to 2 https://www.cdc.gov/niosh/npptl/resources/
concern to the National Institute for Digital Wave Corporation of Centennial, pressrel/letters/respprotect/CA-2018-1006.html.
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Document Created: 2018-09-29 04:26:17
Document Modified: 2018-09-29 04:26:17
| 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 Supplemental Evidence and Data Submissions | |
| Dates | Submission Deadline on or before October 31, 2018. | |
| Contact | Jenae Benns, Telephone: 301-427-1496 or Email: [email protected] | |
| FR Citation | 83 FR 49386 |
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