[Federal Register Volume 83, Number 190 (Monday, October 1, 2018)]
[Notices]
[Pages 49386-49388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21242]


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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

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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 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 Access to published and unpublished 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: [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: Jenae Benns, Telephone: 301-427-1496 
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 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