[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]


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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.

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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our review 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published and unpublished pertinent scientific information will improve 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