Supplemental Evidence and Data Request on Interventions for Dyspnea in Patients With Advanced Cancer, 58719-58721 [2019-23871]

Download as PDF 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 01NON1 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