Supplemental Evidence and Data Request on Interventions for Dyspnea in Patients With Advanced Cancer, 58719-58721 [2019-23871]
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58719
Federal Register / Vol. 84, No. 212 / Friday, November 1, 2019 / Notices
characteristics of employees, and retiree
health insurance is collected through
the establishment questionnaire.
(3) Plan Questionnaire—The purpose
of the mailed Plan Questionnaire is to
collect plan-specific information on
each plan (up to four plans) offered by
establishments that provide health
insurance to their employees. This
questionnaire obtains information on
total premiums, employer and employee
contributions to the premium, and plan
enrollment for each type of coverage
offered—single, employee-plus-one, and
family—within a plan. It also asks for
information on deductibles, copays, and
other plan characteristics.
The primary objective of the MEPS–
IC is to collect information on employersponsored health insurance. Such
information is needed in order to
provide the tools for Federal, State, and
academic researchers to evaluate current
and proposed health policies and to
support the production of important
statistical measures for other Federal
agencies.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents’ time to participate in the
MEPS–IC. The Prescreener
questionnaire will be completed by
29,931 respondents and takes about 5
minutes to complete. The Establishment
questionnaire will be completed by
25,819 respondents and takes about 23
minutes to complete. The Plan
questionnaire will be completed by
22,859 respondents and will require an
average of 2.2 responses per respondent.
Each Plan questionnaire takes about 11
minutes to complete. The total
annualized burden hours are estimated
to be 21,611 hours.
Exhibit 2 shows the estimated
annualized cost burden associated with
the respondents’ time to participate in
this data collection. The annualized cost
burden is estimated to be $705,599.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS FOR THE 2020–2021 MEPS–IC
Number of
respondents
Form name
Number of
responses per
respondent
Hours per
response
Total burden
hours
Prescreener Questionnaire ..............................................................................
Establishment Questionnaire ...........................................................................
Plan Questionnaire ..........................................................................................
29,931
25,819
22,859
1
1
2.2
5/60
* 23/60
11/60
2,494
9,897
9,220
Total ..........................................................................................................
78,609
na
na
21,611
* The burden estimate printed on the establishment questionnaire is 45 minutes which includes the burden estimate for completing the establishment questionnaire and two plan questionnaires (on average, each establishment completes 2.2 plan questionnaires), plus the prescreener.
The establishment and plan questionnaires are sent to the respondent as a package and are completed by the respondent at the same time.
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN FOR THE 2020–2021 MEPS–IC
Number of
respondents
Form name
Total burden
hours
Average
hourly wage
rate *
Total cost
burden
Prescreener Questionnaire ..............................................................................
Establishment Questionnaire ...........................................................................
Plan Questionnaire ..........................................................................................
29,931
25,819
22,859
2,494
9,897
9,220
32.65
32.65
32.65
$81,429
323,137
301,033
Total ..........................................................................................................
78,609
21,611
na
705,599
* Based upon the mean hourly wage for Compensation, Benefits, and Job Analysis Specialists occupation code 13–1141, at https://
www.bls.gov/oes/current/oes131141.htm (U.S. Department of Labor, Bureau of Labor Statistics.)
Request for Comments
In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3521,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ health care research and health
care information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
VerDate Sep<11>2014
19:23 Oct 31, 2019
Jkt 250001
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: October 28, 2019.
Virginia L. Mackay-Smith,
Associate Director.
Fmt 4703
Supplemental Evidence and Data
Request on Interventions for Dyspnea
in Patients With Advanced Cancer
Agency for Healthcare Research
and Quality (AHRQ), HHS.
AGENCY:
Request for supplemental
evidence and data submissions.
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
Interventions for Dyspnea in Patients
with Advanced Cancer, which is
currently being conducted by the
SUMMARY:
BILLING CODE 4160–90–P
Frm 00044
Agency for Healthcare Research and
Quality
ACTION:
[FR Doc. 2019–23872 Filed 10–31–19; 8:45 am]
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Sfmt 4703
E:\FR\FM\01NON1.SGM
01NON1
58720
Federal Register / Vol. 84, No. 212 / Friday, November 1, 2019 / Notices
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 by 30 days
after date of publication of this notice.
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 Interventions for Dyspnea
in Patients with Advanced Cancer.
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 Interventions for Dyspnea
in Patients with Advanced Cancer,
including those that describe adverse
events. The entire research protocol is
available online at: https://
effectivehealthcare.ahrq.gov/products/
dyspnea-advanced-cancer/protocol.
This is to notify the public that the
EPC Program would find the following
information on Interventions for
Dyspnea in Patients with Advanced
Cancer 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, a
summary, including the following
elements: Study number, study period,
VerDate Sep<11>2014
19:23 Oct 31, 2019
Jkt 250001
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 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 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 four (4) weeks. If you would
like to be notified when the draft is
posted, please sign up for the email list
at: https://www.effective
healthcare.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.
Key Questions (KQ)
1. What are the comparative benefits
of non-pharmacological interventions
(either alone or in combination) for
improving dyspnea in patients with
advanced cancer?
2. What are the comparative benefits
of pharmacological interventions (either
alone or in combination) for improving
dyspnea in patients with advanced
cancer?
3. What are the comparative benefits
of non-pharmacological,
pharmacological, and multimodal
interventions for improving dyspnea in
patients with advanced cancer?
4. What are the harms of nonpharmacological and pharmacological
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
interventions for improving dyspnea in
patients with advanced cancer?
PICOTS (Populations, Interventions,
Comparators, Outcomes, Timing,
Settings)
Population(s)
Patients (age ≥ 18 years of age) with
advanced cancer (unlikely to be cured
or unlikely to be controlled with
treatment) and dyspnea.
Interventions
Non-Pharmacological Interventions (KQ
1, 3, and 4)
Respiratory Interventions
a. Airflow/cooling: Fan therapy, water
spray, changing the room
environment (cooling the room/
opening a window)
b. Compressed air
c. Supplemental oxygen therapy (for
hypoxemic and non-hypoxemic
patients)
d. Breathing gas: Heliox
e. Noninvasive Positive-Pressure
Ventilation (Bilevel positive airway
pressure (BiPAP)/Continuous positive
airway pressure (CPAP))
Behavioral and Psychoeducational
Interventions
a. Cognitive-behavioral therapy (CBT)
b. Other behavioral interventions (may
include components such as other
psychosocial interventions, teaching
problem-solving or coping and
adaptation strategies, relaxation/
distraction techniques, biofeedback,
energy conservation)
Activity and Rehabilitation
Interventions
a. Walking aids/mobility aids
b. Exercise (healthcare professionalguided exercise, physical therapy,
occupational therapy, aerobic
exercise, non-aerobic exercise,
isometric exercise, tai chi, qigong)
c. Respiratory training
d. Pulmonary rehabilitation
e. Chest wall vibration
f. Neuromuscular electrical stimulation
(NMES)
Complementary and Alternate Medicine
Interventions
a. Acupuncture
b. Acupressure
c. Reiki
d. Mindfulness
e. Yoga
f. Meditation
g. Music therapy
Combination of any of the above
Pharmacological interventions (drugs
approved by the Food and Drug
Administration (FDA) for any
indication) (KQ 2, 3, and 4).
E:\FR\FM\01NON1.SGM
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Federal Register / Vol. 84, No. 212 / Friday, November 1, 2019 / Notices
Any routes of administration for all
drug classes are included.
• Bronchodilators
a. Beta-adrenergic receptor agonists:
Albuterol, arformoterol, formoterol,
indaceterol, levalbuterol,
olodaterol, terbutaline, vilanterol
b. Antimuscarinics: Aclidinium,
atropine, glycopyrrolate,
ipratropium, scopolamine,
tiotropium, umeclidinium
c. Methylxanthines: Theophylline,
aminophylline, caffeine
• Nebulized saline
• Corticosteroids: Beclomethasone,
betamethasone, budesonide,
ciclesonide, dexamethasone,
flunisolide, fluticasone,
hydrocortisone, methylprednisolone,
mometasone, prednisone
• Diuretics: Amiloride, bumetanide,
ethacrynic acid, furosemide,
hydrochlorothiazide, indapinide,
metolazone, spironolactone,
torsemide, triamterine
• Lidocaine
• Non-steroidal anti-inflammatory
agents: Celecoxib, diclofenac,
diflusinal, etodolac, fenoprofen,
flurbiprofen, ibuprofen,
indomethacin, ketoprofen, ketorolac,
meloxicam, nabumetone, naproxen,
oxaprozin, piroxicam, salsalate,
sulindac, tolmetin
• Phenothiazines: Promethazine,
prochlorperazine, chlorpromazine,
thioridazine
• Atypical antipsychotics: Aripiprazole,
asenapine, brexpiprazole, cariprazine,
clozapine, haloperidol, iloperidone,
lurasidone, olanzapine, paliperidone,
pimavanserin, quetiapine,
risperidone, ziprasidone
• Gamma-Aminobutyric acid (GABA)
analog anticonvulsants: Gabapentin,
pregabalin
• Opioids: Buprenorphine, codeine,
dihydrocodeine, fentanyl,
hydrocodone, hydromorphone,
methadone, morphine, oxycodone,
oxymorphone, tapentadol, tramadol
• Anxiolytics
a. Benzodiazepines: Alprazolam,
clonazepam, diazepam, lorazepam,
midazolam, oxazepam, temazepam
b. Serotonin-norepinephrine reuptake
inhibitors (SNRIs)/Selective
serotonin reuptake inhibitors
(SSRIs): Citalopram,
desvenlafaxine, duloxetine,
escitalopram, fluoxetine,
fluvoxamine, levomilnacipran,
milnacipran, paroxetine, sertraline,
venlafaxine
c. Other: Bupropion, buspirone,
mirtazapine
• Combinations of any of the above
VerDate Sep<11>2014
19:23 Oct 31, 2019
Jkt 250001
Combinations of Nonpharmacologic
and Pharmacologic or Multimodal
Interventions
Comparators
• KQ 1: Placebo, usual care, other nonpharmacological intervention or a
combination of non-pharmacological
interventions
• KQ 2: Placebo, usual care, other
pharmacological intervention or dose
or route, or a combination of
pharmacological interventions
• KQ 3: Placebo, usual care, nonpharmacological interventions,
pharmacologic interventions, or
multimodal interventions (e.g.,
opioids versus respiratory training, or
acupuncture versus morphine versus
combination acupuncture and
morphine)
• KQ 4: Any of the comparators for KQ
1, KQ 2, or KQ 3
Outcomes
Patient- or Caregiver-Reported, or
Observational Symptom-Related
Outcomes (KQ1–3)
Caregiver-Reported or Observational
Symptom-Related Only if Patients are
Unable to Self-Report
• Gastrointestinal (constipation, nausea,
vomiting)
• Pruritus
• Urinary retention, dry mouth
• Opioid use disorder
• Discomfort or distress from
equipment, e.g., oxygen or masks
• Death
• Dropouts
Timing: Any Duration of Follow-up
Setting: Any Setting
Study Design: RCTs for all KQ
• For KQ1–3: RCTs, nonrandomized
controlled trials, and observational
studies with a concurrent comparison
group, with at least 10 patients in
each group
• For KQ 4: RCTs, nonrandomized
controlled trials, observational studies
with a concurrent comparison group,
and prospective or retrospective
cohort studies where the primary
objective of the study is to evaluate
harms from dyspnea treatments
Dated: October 28, 2019.
Virginia L. Mackay-Smith,
Associate Director, Office of the Director,
AHRQ.
[FR Doc. 2019–23871 Filed 10–31–19; 8:45 am]
• Dyspnea as measured by a validated
tool, which must include patient- or
caregiver-reported or observational
symptom-related measures of
breathing difficulty or discomfort
• Anxiety as measured by a validated
tool. This tool must include patientor caregiver-reported measures of
anxiety
• Functional status (measured by
validated patient- or caregiverreported tool)
• Health-related quality of life (general
or disease-specific, measured by a
validated patient- or caregiverreported tool)
BILLING CODE 4160–90–P
Clinical or Utilization Health Outcomes
(KQ1–4)
AGENCY:
• Respiratory rate
• Oxygen or carbon dioxide/bicarbonate
levels
• Heart rate
• Blood pressure
• Objective measure of functional
capacity, e.g., 6-minute walk test
• Level of sedation
• Utilization outcomes linked to
dyspnea: hospitalizations, intensive
care unit stays, emergency room visits
ACTION:
Patient-Centered Adverse Effects of
Dyspnea Treatments (KQ4)
• Central nervous system (cognitive
changes, dizziness, drowsiness,
fatigue, headache, respiratory
depression)
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
58721
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0977]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Regulations
Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco To
Protect Children and Adolescents
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by December
2, 2019.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
SUMMARY:
E:\FR\FM\01NON1.SGM
01NON1
]]>Agencies
[Federal Register Volume 84, Number 212 (Friday, November 1, 2019)]
[Notices]
[Pages 58719-58721]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23871]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Interventions for
Dyspnea in Patients With Advanced Cancer
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 on Interventions
for Dyspnea in Patients with Advanced Cancer, which is currently being
conducted by the
[[Page 58720]]
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 by 30 days after date of publication of this
notice.
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 Interventions for
Dyspnea in Patients with Advanced Cancer. 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 Interventions for Dyspnea in Patients with Advanced
Cancer, including those that describe adverse events. The entire
research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/dyspnea-advanced-cancer/protocol.
This is to notify the public that the EPC Program would find the
following information on Interventions for Dyspnea in Patients with
Advanced Cancer 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, 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 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 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 four (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.
Key Questions (KQ)
1. What are the comparative benefits of non-pharmacological
interventions (either alone or in combination) for improving dyspnea in
patients with advanced cancer?
2. What are the comparative benefits of pharmacological
interventions (either alone or in combination) for improving dyspnea in
patients with advanced cancer?
3. What are the comparative benefits of non-pharmacological,
pharmacological, and multimodal interventions for improving dyspnea in
patients with advanced cancer?
4. What are the harms of non-pharmacological and pharmacological
interventions for improving dyspnea in patients with advanced cancer?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing,
Settings)
Population(s)
Patients (age >= 18 years of age) with advanced cancer (unlikely to
be cured or unlikely to be controlled with treatment) and dyspnea.
Interventions
Non-Pharmacological Interventions (KQ 1, 3, and 4)
Respiratory Interventions
a. Airflow/cooling: Fan therapy, water spray, changing the room
environment (cooling the room/opening a window)
b. Compressed air
c. Supplemental oxygen therapy (for hypoxemic and non-hypoxemic
patients)
d. Breathing gas: Heliox
e. Noninvasive Positive-Pressure Ventilation (Bilevel positive airway
pressure (BiPAP)/Continuous positive airway pressure (CPAP))
Behavioral and Psychoeducational Interventions
a. Cognitive-behavioral therapy (CBT)
b. Other behavioral interventions (may include components such as other
psychosocial interventions, teaching problem-solving or coping and
adaptation strategies, relaxation/distraction techniques, biofeedback,
energy conservation)
Activity and Rehabilitation Interventions
a. Walking aids/mobility aids
b. Exercise (healthcare professional-guided exercise, physical therapy,
occupational therapy, aerobic exercise, non-aerobic exercise, isometric
exercise, tai chi, qigong)
c. Respiratory training
d. Pulmonary rehabilitation
e. Chest wall vibration
f. Neuromuscular electrical stimulation (NMES)
Complementary and Alternate Medicine Interventions
a. Acupuncture
b. Acupressure
c. Reiki
d. Mindfulness
e. Yoga
f. Meditation
g. Music therapy
Combination of any of the above
Pharmacological interventions (drugs approved by the Food and Drug
Administration (FDA) for any indication) (KQ 2, 3, and 4).
[[Page 58721]]
Any routes of administration for all drug classes are included.
Bronchodilators
a. Beta-adrenergic receptor agonists: Albuterol, arformoterol,
formoterol, indaceterol, levalbuterol, olodaterol, terbutaline,
vilanterol
b. Antimuscarinics: Aclidinium, atropine, glycopyrrolate,
ipratropium, scopolamine, tiotropium, umeclidinium
c. Methylxanthines: Theophylline, aminophylline, caffeine
Nebulized saline
Corticosteroids: Beclomethasone, betamethasone, budesonide,
ciclesonide, dexamethasone, flunisolide, fluticasone, hydrocortisone,
methylprednisolone, mometasone, prednisone
Diuretics: Amiloride, bumetanide, ethacrynic acid, furosemide,
hydrochlorothiazide, indapinide, metolazone, spironolactone, torsemide,
triamterine
Lidocaine
Non-steroidal anti-inflammatory agents: Celecoxib, diclofenac,
diflusinal, etodolac, fenoprofen, flurbiprofen, ibuprofen,
indomethacin, ketoprofen, ketorolac, meloxicam, nabumetone, naproxen,
oxaprozin, piroxicam, salsalate, sulindac, tolmetin
Phenothiazines: Promethazine, prochlorperazine,
chlorpromazine, thioridazine
Atypical antipsychotics: Aripiprazole, asenapine,
brexpiprazole, cariprazine, clozapine, haloperidol, iloperidone,
lurasidone, olanzapine, paliperidone, pimavanserin, quetiapine,
risperidone, ziprasidone
Gamma-Aminobutyric acid (GABA) analog anticonvulsants:
Gabapentin, pregabalin
Opioids: Buprenorphine, codeine, dihydrocodeine, fentanyl,
hydrocodone, hydromorphone, methadone, morphine, oxycodone,
oxymorphone, tapentadol, tramadol
Anxiolytics
a. Benzodiazepines: Alprazolam, clonazepam, diazepam, lorazepam,
midazolam, oxazepam, temazepam
b. Serotonin-norepinephrine reuptake inhibitors (SNRIs)/Selective
serotonin reuptake inhibitors (SSRIs): Citalopram, desvenlafaxine,
duloxetine, escitalopram, fluoxetine, fluvoxamine, levomilnacipran,
milnacipran, paroxetine, sertraline, venlafaxine
c. Other: Bupropion, buspirone, mirtazapine
Combinations of any of the above
Combinations of Nonpharmacologic and Pharmacologic or Multimodal
Interventions
Comparators
KQ 1: Placebo, usual care, other non-pharmacological
intervention or a combination of non-pharmacological interventions
KQ 2: Placebo, usual care, other pharmacological intervention
or dose or route, or a combination of pharmacological interventions
KQ 3: Placebo, usual care, non-pharmacological interventions,
pharmacologic interventions, or multimodal interventions (e.g., opioids
versus respiratory training, or acupuncture versus morphine versus
combination acupuncture and morphine)
KQ 4: Any of the comparators for KQ 1, KQ 2, or KQ 3
Outcomes
Patient- or Caregiver-Reported, or Observational Symptom-Related
Outcomes (KQ1-3)
Caregiver-Reported or Observational Symptom-Related Only if Patients
are Unable to Self-Report
Dyspnea as measured by a validated tool, which must include
patient- or caregiver-reported or observational symptom-related
measures of breathing difficulty or discomfort
Anxiety as measured by a validated tool. This tool must
include patient-or caregiver-reported measures of anxiety
Functional status (measured by validated patient- or
caregiver-reported tool)
Health-related quality of life (general or disease-specific,
measured by a validated patient- or caregiver-reported tool)
Clinical or Utilization Health Outcomes (KQ1-4)
Respiratory rate
Oxygen or carbon dioxide/bicarbonate levels
Heart rate
Blood pressure
Objective measure of functional capacity, e.g., 6-minute walk
test
Level of sedation
Utilization outcomes linked to dyspnea: hospitalizations,
intensive care unit stays, emergency room visits
Patient-Centered Adverse Effects of Dyspnea Treatments (KQ4)
Central nervous system (cognitive changes, dizziness,
drowsiness, fatigue, headache, respiratory depression)
Gastrointestinal (constipation, nausea, vomiting)
Pruritus
Urinary retention, dry mouth
Opioid use disorder
Discomfort or distress from equipment, e.g., oxygen or masks
Death
Dropouts
Timing: Any Duration of Follow-up
Setting: Any Setting
Study Design: RCTs for all KQ
For KQ1-3: RCTs, nonrandomized controlled trials, and
observational studies with a concurrent comparison group, with at least
10 patients in each group
For KQ 4: RCTs, nonrandomized controlled trials, observational
studies with a concurrent comparison group, and prospective or
retrospective cohort studies where the primary objective of the study
is to evaluate harms from dyspnea treatments
Dated: October 28, 2019.
Virginia L. Mackay-Smith,
Associate Director, Office of the Director, AHRQ.
[FR Doc. 2019-23871 Filed 10-31-19; 8:45 am]
BILLING CODE 4160-90-P
