83_FR_8520 83 FR 8481 - Supplemental Evidence and Data Request on Home Mechanical Ventilators

83 FR 8481 - Supplemental Evidence and Data Request on Home Mechanical Ventilators

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality

Federal Register Volume 83, Issue 39 (February 27, 2018)

Page Range8481-8482
FR Document2018-03927

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 Access to published and unpublished pertinent scientific information will improve the quality of this review.

Federal Register, Volume 83 Issue 39 (Tuesday, February 27, 2018) 
[Federal Register Volume 83, Number 39 (Tuesday, February 27, 2018)]
[Notices]
[Pages 8481-8482]
From the Federal Register Online  [www.thefederalregister.org]
[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unpublished pertinent scientific information will improve the quality 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

Federal Register / Vol. 83, No. 39 / Tuesday, February 27, 2018 / Notices 8481 DEPARTMENT OF HEALTH AND from the public (e.g., details of studies https://www.effectivehealthcare.ahrq. HUMAN SERVICES conducted). We are looking for studies gov/email-updates. that report on Home Mechanical The systematic review will answer the Agency for Healthcare Research and Ventilators, including those that following questions. This information is Quality describe adverse events. The entire provided as background. AHRQ is not research protocol, including the key requesting that the public provide Supplemental Evidence and Data questions, is also available online at: answers to these questions. Request on Home Mechanical https://www.ahrq.gov/research/ Ventilators The Key Questions findings/ta/index.html. This is to notify the public that the I. What are the patient characteristics AGENCY: Agency for Healthcare Research and/or laboratory criteria and/or target and Quality (AHRQ), HHS. EPC Program would find the following information on Home Mechanical level measurable improvements ACTION: Request for supplemental considered for the initiation and Ventilators helpful: evidence and data submissions. continuation of noninvasive positive D A list of completed studies that your organization has sponsored for this pressure ventilation supplied by a Home SUMMARY: The Agency for Healthcare indication. In the list, please indicate Mechanical Ventilator (HMV), Bilevel Research and Quality (AHRQ) is seeking whether results are available on Positive Airway Pressure device (BPAP), scientific information submissions from ClinicalTrials.gov along with the and Continuous Positive Airway the public. Scientific information is ClinicalTrials.gov trial number. Pressure device (CPAP) in the home being solicited to inform our review of D For completed studies that do not through a noninvasive interface for the Home Mechanical Ventilators, which is have results on ClinicalTrials.gov, population of patients with chronic currently being conducted by the please provide a summary, including respiratory failure due to neuromuscular AHRQ’s Evidence-based Practice the following elements: Study number, diseases, thoracic restrictive diseases, Centers (EPC) Program. Access to study period, design, methodology, chronic obstructive pulmonary diseases published and unpublished pertinent indication and diagnosis, proper use (COPD), or other lung diseases (cystic scientific information will improve the instructions, inclusion and exclusion fibrosis, bronchiectasis)? quality of this review. A. What are the patient characteristics DATES: Submission Deadline on or criteria, primary and secondary and/or laboratory criteria and/or target before March 29, 2018. outcomes, baseline characteristics, level measurable improvements (e.g. number of patients screened/eligible/ ADDRESSES: reduction in hypercapnia) considered enrolled/lost to follow-up/withdrawn/ Email submissions: epc@ for the initiation and continuation of analyzed, effectiveness/efficacy, and ahrq.hhs.gov. noninvasive positive pressure safety results. Print submissions: mechanical ventilation supplied by a D A list of ongoing studies that your Mailing Address: Center for Evidence HMV through a noninvasive interface in organization has sponsored for this and Practice Improvement, Agency for the home? indication. In the list, please provide the B. What are the patient characteristics Healthcare Research and Quality, ClinicalTrials.gov trial number or, if the and/or laboratory criteria and/or target ATTN: EPC SEADs Coordinator, 5600 trial is not registered, the protocol for level measurable improvements (e.g. Fishers Lane, Mail Stop 06E53A, the study including a study number, the reduction in hypercapnia) considered Rockville, MD 20857. study period, design, methodology, for the initiation and continuation of Shipping Address (FedEx, UPS, etc.): indication and diagnosis, proper use noninvasive positive pressure Center for Evidence and Practice instructions, inclusion and exclusion ventilation supplied as a BPAP through Improvement, Agency for Healthcare criteria, and primary and secondary a noninvasive interface in the home? Research and Quality, ATTN: EPC outcomes. C. What are the patient characteristics SEADs Coordinator, 5600 Fishers Lane, D Description of whether the above and/or laboratory criteria and/or target Mail Stop 06E77D, Rockville, MD studies constitute All Phase II and above level measurable improvements (e.g. 20857. clinical trials sponsored by your reduction in hypercapnia) considered FOR FURTHER INFORMATION CONTACT: organization for this indication and an for the initiation and continuation of Jenae Benns, Center for Evidence and index outlining the relevant information noninvasive positive pressure Practice and Improvement, (301) 427– in each submitted file. ventilation supplied as a CPAP through 1496. Your contribution will be very a noninvasive interface in the home? Email: epc@ahrq.hhs.gov. beneficial to the EPC Program. Materials II. In each of the above groups, what SUPPLEMENTARY INFORMATION: The submitted must be publicly available or is the effect of HMV, a BPAP, or a CPAP Agency for Healthcare Research and able to be made public. Materials that use on patient outcomes, including Quality has commissioned the are considered confidential; marketing mortality, hospitalization, admission/ Evidence-based Practice Centers (EPC) materials; study types not included in readmission to intensive care unit (ICU), Program to complete a review of the the review; or information on need for intubation, outpatient visits, evidence for Home Mechanical indications not included in the review emergency room visits, disease Ventilators. AHRQ is conducting this cannot be used by the EPC Program. exacerbations, quality of life (QoL), systematic review pursuant to Section This is a voluntary request for activities of daily living (ADL), dyspnea, 902(a) of the Public Health Service Act, information, and all costs for complying sleep quality, exercise tolerance, and 42 U.S.C. 299a(a). with this request must be borne by the adverse events? daltland on DSKBBV9HB2PROD with NOTICES The EPC Program is dedicated to submitter. III. What are the equipment identifying as many studies as possible The draft of this review will be posted parameters that are used in each of the that are relevant to the questions for on AHRQ’s EPC Program website and above groups? each of its reviews. In order to do so, we available for public comment for a A. What are the parameters of are supplementing the usual manual period of 4 weeks. If you would like to ventilator usage (e.g. mode as and electronic database searches of the be notified when the draft is posted, determined by trigger, control and literature by requesting information please sign up for the email list at: cycling variables)? VerDate Sep<11>2014 21:07 Feb 26, 2018 Jkt 244001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\27FEN1.SGM 27FEN1

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


Document Created: 2018-02-27 01:14:37
Document Modified: 2018-02-27 01:14:37
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionRequest for supplemental evidence and data submissions.
DatesSubmission Deadline on or before March 29, 2018.
ContactJenae Benns, Center for Evidence and Practice and Improvement, (301) 427-1496.
FR Citation83 FR 8481 
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