Supplemental Evidence and Data Request on Home Mechanical Ventilators, 8481-8482 [2018-03927]

Download as PDF Federal Register / Vol. 83, No. 39 / Tuesday, February 27, 2018 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Supplemental Evidence and Data Request on Home Mechanical Ventilators Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for supplemental evidence and data submissions. AGENCY: 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 Home Mechanical Ventilators, 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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 March 29, 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. SUMMARY: daltland on DSKBBV9HB2PROD with NOTICES FOR FURTHER INFORMATION CONTACT: Jenae Benns, Center for Evidence and Practice and Improvement, (301) 427– 1496. 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 Home Mechanical Ventilators. 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 literature by requesting information VerDate Sep<11>2014 21:07 Feb 26, 2018 Jkt 244001 from the public (e.g., details of studies conducted). We are looking for studies that report on Home Mechanical Ventilators, including those that describe adverse events. The entire research protocol, including the key questions, is also available online at: https://www.ahrq.gov/research/ findings/ta/index.html. This is to notify the public that the EPC Program would find the following information on Home Mechanical Ventilators helpful: D 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. D 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. D 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. D 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: PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 8481 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 patient characteristics and/or laboratory criteria and/or target level measurable improvements considered for the initiation and continuation of noninvasive positive pressure ventilation supplied by a Home Mechanical Ventilator (HMV), Bilevel Positive Airway Pressure device (BPAP), and Continuous Positive Airway Pressure device (CPAP) in the home through a noninvasive interface for the population of patients with chronic respiratory failure due to neuromuscular diseases, thoracic restrictive diseases, chronic obstructive pulmonary diseases (COPD), or other lung diseases (cystic fibrosis, bronchiectasis)? A. What are the patient characteristics and/or laboratory criteria and/or target level measurable improvements (e.g. reduction in hypercapnia) considered for the initiation and continuation of noninvasive positive pressure mechanical ventilation supplied by a HMV through a noninvasive interface in the home? B. What are the patient characteristics and/or laboratory criteria and/or target level measurable improvements (e.g. reduction in hypercapnia) considered for the initiation and continuation of noninvasive positive pressure ventilation supplied as a BPAP through a noninvasive interface in the home? C. What are the patient characteristics and/or laboratory criteria and/or target level measurable improvements (e.g. reduction in hypercapnia) considered for the initiation and continuation of noninvasive positive pressure ventilation supplied as a CPAP through a noninvasive interface in the home? II. In each of the above groups, what is the effect of HMV, a BPAP, or a CPAP use on patient outcomes, including mortality, hospitalization, admission/ readmission to intensive care unit (ICU), need for intubation, outpatient visits, emergency room visits, disease exacerbations, quality of life (QoL), activities of daily living (ADL), dyspnea, sleep quality, exercise tolerance, and adverse events? III. What are the equipment parameters that are used in each of the above groups? A. What are the parameters of ventilator usage (e.g. mode as determined by trigger, control and cycling variables)? E:\FR\FM\27FEN1.SGM 27FEN1 8482 Federal Register / Vol. 83, No. 39 / Tuesday, February 27, 2018 / Notices B. What are the equipment parameters that are necessary to achieve desired outcomes (e.g. flow capabilities, settings, etc.)? C. What are the parameters of prescribed patient usage (e.g. frequency of use, duration of use throughout the day, other)? D. In each of the above populations, what are the parameters of patient compliance with the prescribed usage of the equipment? IV. What respiratory services, other than the technical support of the use of the prescribed equipment, are being provided to the above patients in the home (e.g. patient education, ongoing smoking cessation, respiratory therapist led home care)? V. What are the professional guidelines and statements which address KQ 1 to KQ 4? PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, Settings) daltland on DSKBBV9HB2PROD with NOTICES Interventions I. Home mechanical ventilators (FDAapproved only) with or without pertinent ancillary in-home services (e.g. respiratory therapy in the home; pharmacy reconciliation; smoking cessation, etc.) II. BPAP respiratory assist devices (FDA-approved only) w/or w/o pertinent ancillary in-home services III. CPAP respiratory assist devices (FDA-approved only) w/or w/o pertinent ancillary in-home services Comparators I. Usual care (i.e. no mechanical ventilation/BPAP/CPAP) II. Different type of noninvasive mechanical ventilation III. Different modes of same equipment IV. Other noninvasive ventilation (Studies without a comparator treatment that evaluate the effect of a patient characteristic, laboratory criteria, ventilator parameter, or respiratory services on outcomes of interest will be included) Patient-Centered Outcomes I. Mortality VerDate Sep<11>2014 19:49 Feb 26, 2018 Jkt 244001 Timing Rockville, Maryland, 20857, (301) 427– 1456. For press-related information, please contact Alison Hunt at (301) 427– 1244 or at Alison.Hunt@ahrq.hhs.gov. Closed captioning will be provided during the WebEx. If another accommodation for a disability is needed, please contact the Food and Drug Administration (FDA) Office of Equal Employment Opportunity and Diversity Management on (301) 827– 4840, no later than Friday, March 9, 2018. I. At least 1 month of treatment SUPPLEMENTARY INFORMATION: Setting I. Purpose I. Home II. Assisted living residence The National Advisory Council for Healthcare Research and Quality is authorized by Section 941 of the Public Health Service Act, 42 U.S.C. 299c. In accordance with its statutory mandate, the Council is to advise the Secretary of the Department of Health and Human Services and the Director of AHRQ on matters related to AHRQ’s conduct of its mission including providing guidance on (A) priorities for health care research, (B) the field of health care research including training needs and information dissemination on health care quality and (C) the role of the Agency in light of private sector activity and opportunities for public private partnerships. The Council is composed of members of the public, appointed by the Secretary, and Federal ex-officio members specified in the authorizing legislation. Publication Time I. From 1995 Subgroup Analysis Population(s) I. Adults 18 years and older with chronic respiratory failure due to: A. Neuromuscular diseases B. Thoracic restrictive diseases (including thoracic cage abnormalities and morbid obesity) C. Chronic obstructive pulmonary disease D. Other lung diseases (cystic fibrosis, bronchiectasis) Outcomes II. Hospitalization III. Admission/readmission to intensive care unit (ICU) IV. Need for intubation V. Outpatient visits VI. Emergency room visits VII. Disease exacerbations VIII. Quality of life (QoL) IX. Activities of daily living (ADL) X. Dyspnea XI. Sleep quality XII. Exercise tolerance XIII. Adverse events I. Type of diseases A. Neuromuscular diseases B. Thoracic restrictive diseases i. Thoracic cage abnormalities ii. Morbid obesity C. COPD D. Other lung diseases (cystic fibrosis, bronchiectasis) II. Length of treatment (1 month, 3 months, 6 months and longer) Karen J. Migdail, Chief of Staff. [FR Doc. 2018–03927 Filed 2–26–18; 8:45 am] BILLING CODE 4160–90–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Meeting of the National Advisory Council for Healthcare Research and Quality Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Notice of public meeting. AGENCY: This notice announces a meeting of the National Advisory Council for Healthcare Research and Quality. SUMMARY: The meeting will be held on Friday, March 16, 2018, from 11:00 a.m. to 1:00 p.m. (EST). ADDRESSES: The meeting will be held virtually (via WebEx). FOR FURTHER INFORMATION CONTACT: Jaime Zimmerman, Designated Management Official, at the Agency for Healthcare Research and Quality, 5600 Fishers Lane, Mail Stop 06E37A, DATES: PO 00000 Frm 00065 Fmt 4703 Sfmt 9990 II. Agenda On Friday, March 16, 2018, the Council meeting will convene via WebEx at 11:00 a.m. (EST), with the call to order by the Council Chair and approval of previous Council summary notes. The agenda will include an update by the AHRQ Director and an update on the Healthcare Cost and Utilization Project (HCUP) new release of county level statistics on hospital stays for alcohol, opioids, and other drugs. The meeting is open to the public. For information regarding how to access the WebEx as well as other meeting details, please go to https:// www.ahrq.gov/news/events/nac/. Karen J. Migdail, Chief of Staff. [FR Doc. 2018–03926 Filed 2–26–18; 8:45 am] BILLING CODE 4160–90–P E:\FR\FM\27FEN1.SGM 27FEN1

Agencies

[Federal Register Volume 83, Number 39 (Tuesday, February 27, 2018)]
[Notices]
[Pages 8481-8482]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03927]



[[Page 8481]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Home Mechanical 
Ventilators

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 Home Mechanical 
Ventilators, 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 March 29, 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, Center for Evidence and 
Practice and Improvement, (301) 427-1496.
    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 Home Mechanical 
Ventilators. 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 literature by requesting information from the 
public (e.g., details of studies conducted). We are looking for studies 
that report on Home Mechanical Ventilators, including those that 
describe adverse events. The entire research protocol, including the 
key questions, is also available online at: https://www.ahrq.gov/research/findings/ta/index.html.
    This is to notify the public that the EPC Program would find the 
following information on Home Mechanical Ventilators 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 patient characteristics and/or laboratory criteria 
and/or target level measurable improvements considered for the 
initiation and continuation of noninvasive positive pressure 
ventilation supplied by a Home Mechanical Ventilator (HMV), Bilevel 
Positive Airway Pressure device (BPAP), and Continuous Positive Airway 
Pressure device (CPAP) in the home through a noninvasive interface for 
the population of patients with chronic respiratory failure due to 
neuromuscular diseases, thoracic restrictive diseases, chronic 
obstructive pulmonary diseases (COPD), or other lung diseases (cystic 
fibrosis, bronchiectasis)?
    A. What are the patient characteristics and/or laboratory criteria 
and/or target level measurable improvements (e.g. reduction in 
hypercapnia) considered for the initiation and continuation of 
noninvasive positive pressure mechanical ventilation supplied by a HMV 
through a noninvasive interface in the home?
    B. What are the patient characteristics and/or laboratory criteria 
and/or target level measurable improvements (e.g. reduction in 
hypercapnia) considered for the initiation and continuation of 
noninvasive positive pressure ventilation supplied as a BPAP through a 
noninvasive interface in the home?
    C. What are the patient characteristics and/or laboratory criteria 
and/or target level measurable improvements (e.g. reduction in 
hypercapnia) considered for the initiation and continuation of 
noninvasive positive pressure ventilation supplied as a CPAP through a 
noninvasive interface in the home?
    II. In each of the above groups, what is the effect of HMV, a BPAP, 
or a CPAP use on patient outcomes, including mortality, 
hospitalization, admission/readmission to intensive care unit (ICU), 
need for intubation, outpatient visits, emergency room visits, disease 
exacerbations, quality of life (QoL), activities of daily living (ADL), 
dyspnea, sleep quality, exercise tolerance, and adverse events?
    III. What are the equipment parameters that are used in each of the 
above groups?
    A. What are the parameters of ventilator usage (e.g. mode as 
determined by trigger, control and cycling variables)?

[[Page 8482]]

    B. What are the equipment parameters that are necessary to achieve 
desired outcomes (e.g. flow capabilities, settings, etc.)?
    C. What are the parameters of prescribed patient usage (e.g. 
frequency of use, duration of use throughout the day, other)?
    D. In each of the above populations, what are the parameters of 
patient compliance with the prescribed usage of the equipment?
    IV. What respiratory services, other than the technical support of 
the use of the prescribed equipment, are being provided to the above 
patients in the home (e.g. patient education, ongoing smoking 
cessation, respiratory therapist led home care)?
    V. What are the professional guidelines and statements which 
address KQ 1 to KQ 4?

PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, 
Settings)

Population(s)

I. Adults 18 years and older with chronic respiratory failure due to:
    A. Neuromuscular diseases
    B. Thoracic restrictive diseases (including thoracic cage 
abnormalities and morbid obesity)
    C. Chronic obstructive pulmonary disease
    D. Other lung diseases (cystic fibrosis, bronchiectasis)

Interventions

I. Home mechanical ventilators (FDA-approved only) with or without 
pertinent ancillary in-home services (e.g. respiratory therapy in the 
home; pharmacy reconciliation; smoking cessation, etc.)
II. BPAP respiratory assist devices (FDA-approved only) w/or w/o 
pertinent ancillary in-home services
III. CPAP respiratory assist devices (FDA-approved only) w/or w/o 
pertinent ancillary in-home services

Comparators

I. Usual care (i.e. no mechanical ventilation/BPAP/CPAP)
II. Different type of noninvasive mechanical ventilation
III. Different modes of same equipment
IV. Other noninvasive ventilation

    (Studies without a comparator treatment that evaluate the effect of 
a patient characteristic, laboratory criteria, ventilator parameter, or 
respiratory services on outcomes of interest will be included)

Outcomes

Patient-Centered Outcomes
I. Mortality
II. Hospitalization
III. Admission/readmission to intensive care unit (ICU)
IV. Need for intubation
V. Outpatient visits
VI. Emergency room visits
VII. Disease exacerbations
VIII. Quality of life (QoL)
IX. Activities of daily living (ADL)
X. Dyspnea
XI. Sleep quality
XII. Exercise tolerance
XIII. Adverse events
Timing
I. At least 1 month of treatment
Setting
I. Home
II. Assisted living residence
Publication Time
I. From 1995
Subgroup Analysis
I. Type of diseases
    A. Neuromuscular diseases
    B. Thoracic restrictive diseases
    i. Thoracic cage abnormalities
    ii. Morbid obesity
    C. COPD
    D. Other lung diseases (cystic fibrosis, bronchiectasis)
II. Length of treatment (1 month, 3 months, 6 months and longer)

Karen J. Migdail,
Chief of Staff.
[FR Doc. 2018-03927 Filed 2-26-18; 8:45 am]
 BILLING CODE 4160-90-P