Supplemental Evidence and Data Request on Noninvasive Nonpharmacologic Treatment for Chronic Pain, 10087-10088 [2019-05143]
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10087
Federal Register / Vol. 84, No. 53 / Tuesday, March 19, 2019 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
Form name
Total burden
hours
Average
hourly wage
rate *
Total cost
burden
Registration Form ............................................................................................
Program Information Form ..............................................................................
Data Use Agreement .......................................................................................
Data Files Submission .....................................................................................
51
51
51
13
4.25
4.25
2.5
52
a 53.69
c 42.08
$228
228
236
2,188
Total ..........................................................................................................
** 166
63
NA
2,880
a 53.69
b 94.25
* National Compensation Survey: Occupational wages in the United States May 2017, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’
a Based on the mean hourly wage for Medical and Health Services Managers (11–9111).
b Based on the mean hourly wage for Chief Executives (11–1011).
c Based on the mean hourly wages for Computer Programmer (15–1131).
** The 51 POCs listed for the registration form, program information form and the data use agreement are the estimated POCs from the estimated participating programs.
Request for Comments
In accordance with the Paperwork
Reduction Act, 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’s 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
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.
Gopal Khanna,
Director.
[FR Doc. 2019–05141 Filed 3–18–19; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Noninvasive
Nonpharmacologic Treatment for
Chronic Pain
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for supplemental
evidence and data submissions.
AGENCY:
VerDate Sep<11>2014
17:54 Mar 18, 2019
Jkt 247001
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
Noninvasive Nonpharmacologic
Treatment for Chronic Pain, 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 April 18, 2019.
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 Noninvasive
Nonpharmacologic Treatment for
Chronic Pain. 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
SUMMARY:
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
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 Noninvasive
Nonpharmacologic Treatment for
Chronic Pain, including those that
describe adverse events. The entire
research protocol is available online at:
https://effectivehealthcare.ahrq.gov/
topics/noninvasive-nonpharm-painupdate/protocol.
This is to notify the public that the
EPC Program would find the following
information on Noninvasive
Nonpharmacologic Treatment for
Chronic Pain helpful:
D A list of completed studies that
your organization has sponsored for this
indication. In the list, please indicate
whether results are available on
ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
D For completed studies that do not
have results on ClinicalTrials.gov,
please provide a summary, including
the following elements: Study number,
study period, design, methodology,
indication and diagnosis, proper use
instructions, inclusion and exclusion
criteria, primary and secondary
outcomes, baseline characteristics,
number of patients screened/eligible/
enrolled/lost to follow-up/withdrawn/
analyzed, effectiveness/efficacy, and
safety results.
D A list of ongoing studies that your
organization has sponsored for this
indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the
trial is not registered, the protocol for
the study including a study number, the
study period, design, methodology,
indication and diagnosis, proper use
instructions, inclusion and exclusion
criteria, and primary and secondary
outcomes.
D Description of whether the above
studies constitute ALL Phase II and
above clinical trials sponsored by your
E:\FR\FM\19MRN1.SGM
19MRN1
10088
Federal Register / Vol. 84, No. 53 / Tuesday, March 19, 2019 / Notices
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
1. In adults with chronic low back
pain:
a. What are the benefits and harms of
noninvasive nonpharmacologic
therapies compared with sham
treatment, no treatment, waitlist,
attention control, or usual care?
b. What are the benefits and harms of
noninvasive nonpharmacologic
therapies compared with pharmacologic
therapy (e.g., NSAIDS, acetaminophen,
antiseizure medications,
antidepressants)?
c. What are the benefits and harms of
noninvasive nonpharmacologic
therapies compared with exercise?
2. In adults with chronic neck pain:
a. What are the benefits and harms of
noninvasive nonpharmacologic
therapies compared with sham
treatment, no treatment, waitlist,
attention control, or usual care?
b. What are the benefits and harms of
noninvasive nonpharmacologic
therapies compared with pharmacologic
therapy?
c. What are the benefits and harms of
noninvasive nonpharmacologic
therapies compared with exercise?
3. In adults with osteoarthritis-related
pain:
a. What are the benefits and harms of
noninvasive nonpharmacologic
therapies compared with sham
treatment, no treatment, waitlist,
attention control, or usual care?
VerDate Sep<11>2014
17:54 Mar 18, 2019
Jkt 247001
b. What are the benefits and harms of
noninvasive nonpharmacologic
therapies compared with pharmacologic
therapy?
c. What are the benefits and harms of
noninvasive nonpharmacologic
therapies compared with exercise?
4. In adults with fibromyalgia:
a. What are the benefits and harms of
noninvasive nonpharmacologic
therapies compared with sham
treatment, no treatment, waitlist,
attention control, or usual care?
b. What are the benefits and harms of
noninvasive nonpharmacologic
therapies compared with pharmacologic
therapy?
c. What are the benefits and harms of
noninvasive nonpharmacologic
therapies compared with exercise?
5. In adults with chronic tension
headache:
a. What are the benefits and harms of
noninvasive nonpharmacologic
therapies compared with sham
treatment, no treatment, waitlist,
attention control, or usual care?
b. What are the benefits and harms of
noninvasive nonpharmacologic
therapies compared with pharmacologic
therapy?
c. What are the benefits and harms of
noninvasive nonpharmacologic
therapies compared with biofeedback?
6. Do estimates of benefits and harms
differ by age, sex, presence of
comorbidities (e.g., emotional or mood
disorders) or degree of nociplasticity/
central sensitization?
PICOTS (Populations, Interventions,
Comparators, Outcomes, Timing,
Settings)
• Population(s): Adults (including
pregnant or breastfeeding women) with
the following chronic pain (defined as
pain lasting 12 weeks or longer or pain
persisting past the time for normal
tissue healing) conditions specified in
the Key Questions:
Æ Key Question 1: Nonradicular
chronic low back pain.
Æ Key Question 2: Chronic neck pain
without radiculopathy or myelopathy.
Æ Key Question 3: Pain related to
primary or secondary osteoarthritis.
Æ Key Question 4: Fibromyalgia.
Æ Key Question 5: Primary chronic
tension headache (defined as 15 or more
headache days per month for at least 3
months).
Æ Key Question 6: Patients with any
of the five chronic pain conditions.
• Interventions (All Key Questions):
Æ Exercise.
Æ Psychological therapies.
Æ Physical modalities.
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
Æ Manual therapies.
Æ Mindfulness practices.
Æ Mind-body practices.
Æ Acupuncture.
Æ Multidisciplinary/interdisciplinary
rehabilitation (including functional
restoration training).
• Comparators:
Æ For all Key Questions, subquestion
‘‘a’’.
D Sham treatment.
D Waitlist.
D Usual care.
D Attention control.
D No treatment.
Æ For all Key Questions, subquestion
‘‘b’’.
D Common nonopioid pharmacologic
therapy used for chronic pain (NSAIDs,
acetaminophen, antiseizure
medications, antidepressants, muscle
relaxants (including benzodiazepines)
topical agents,(diclofenac, lidocaine
capsaicin).
D Medical marijuana (any
formulation).
D Opioid analgesics.
Æ Key Questions 1–4, 6, subquestion
‘‘c’’: Exercise.
Æ Key Question 5, 6, subquestion ‘‘c’’:
Biofeedback.
• Outcomes:
Æ Primary efficacy outcomes (in
priority order); we will focus on
outcomes from validated measures.
D Function/disability/pain
interference.
D Pain.
Æ Harms and adverse effects.
Æ Secondary outcomes.
D Psychological distress (including
depression and anxiety).
D Quality of life.
D Opioid use.
D Sleep quality, sleep disturbance.
D Health care utilization.
• Timing:
Æ Duration of followup: short term
(up to 6 months), intermediate term (6–
12 months) and long term (at least 1
year); we will focus on longer-term (≤1
year) effects where possible.
Æ Studies with <1 month followup
after treatment will be excluded.
• Settings:
Æ Any nonhospital setting or setting
of self-directed care.
Æ Exclusions: Hospital care, hospice
care, emergency department care.
Gopal Khanna,
Director.
[FR Doc. 2019–05143 Filed 3–18–19; 8:45 am]
BILLING CODE 4160–90–P
E:\FR\FM\19MRN1.SGM
19MRN1
]]>Agencies
[Federal Register Volume 84, Number 53 (Tuesday, March 19, 2019)]
[Notices]
[Pages 10087-10088]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05143]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Noninvasive
Nonpharmacologic Treatment for Chronic Pain
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 Noninvasive
Nonpharmacologic Treatment for Chronic Pain, 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 April 18, 2019.
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 Noninvasive
Nonpharmacologic Treatment for Chronic Pain. 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 Noninvasive Nonpharmacologic Treatment for Chronic Pain,
including those that describe adverse events. The entire research
protocol is available online at: https://effectivehealthcare.ahrq.gov/topics/noninvasive-nonpharm-pain-update/protocol.
This is to notify the public that the EPC Program would find the
following information on Noninvasive Nonpharmacologic Treatment for
Chronic Pain 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
[[Page 10088]]
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
1. In adults with chronic low back pain:
a. What are the benefits and harms of noninvasive nonpharmacologic
therapies compared with sham treatment, no treatment, waitlist,
attention control, or usual care?
b. What are the benefits and harms of noninvasive nonpharmacologic
therapies compared with pharmacologic therapy (e.g., NSAIDS,
acetaminophen, antiseizure medications, antidepressants)?
c. What are the benefits and harms of noninvasive nonpharmacologic
therapies compared with exercise?
2. In adults with chronic neck pain:
a. What are the benefits and harms of noninvasive nonpharmacologic
therapies compared with sham treatment, no treatment, waitlist,
attention control, or usual care?
b. What are the benefits and harms of noninvasive nonpharmacologic
therapies compared with pharmacologic therapy?
c. What are the benefits and harms of noninvasive nonpharmacologic
therapies compared with exercise?
3. In adults with osteoarthritis-related pain:
a. What are the benefits and harms of noninvasive nonpharmacologic
therapies compared with sham treatment, no treatment, waitlist,
attention control, or usual care?
b. What are the benefits and harms of noninvasive nonpharmacologic
therapies compared with pharmacologic therapy?
c. What are the benefits and harms of noninvasive nonpharmacologic
therapies compared with exercise?
4. In adults with fibromyalgia:
a. What are the benefits and harms of noninvasive nonpharmacologic
therapies compared with sham treatment, no treatment, waitlist,
attention control, or usual care?
b. What are the benefits and harms of noninvasive nonpharmacologic
therapies compared with pharmacologic therapy?
c. What are the benefits and harms of noninvasive nonpharmacologic
therapies compared with exercise?
5. In adults with chronic tension headache:
a. What are the benefits and harms of noninvasive nonpharmacologic
therapies compared with sham treatment, no treatment, waitlist,
attention control, or usual care?
b. What are the benefits and harms of noninvasive nonpharmacologic
therapies compared with pharmacologic therapy?
c. What are the benefits and harms of noninvasive nonpharmacologic
therapies compared with biofeedback?
6. Do estimates of benefits and harms differ by age, sex, presence
of comorbidities (e.g., emotional or mood disorders) or degree of
nociplasticity/central sensitization?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing,
Settings)
Population(s): Adults (including pregnant or breastfeeding
women) with the following chronic pain (defined as pain lasting 12
weeks or longer or pain persisting past the time for normal tissue
healing) conditions specified in the Key Questions:
[cir] Key Question 1: Nonradicular chronic low back pain.
[cir] Key Question 2: Chronic neck pain without radiculopathy or
myelopathy.
[cir] Key Question 3: Pain related to primary or secondary
osteoarthritis.
[cir] Key Question 4: Fibromyalgia.
[cir] Key Question 5: Primary chronic tension headache (defined as
15 or more headache days per month for at least 3 months).
[cir] Key Question 6: Patients with any of the five chronic pain
conditions.
Interventions (All Key Questions):
[cir] Exercise.
[cir] Psychological therapies.
[cir] Physical modalities.
[cir] Manual therapies.
[cir] Mindfulness practices.
[cir] Mind-body practices.
[cir] Acupuncture.
[cir] Multidisciplinary/interdisciplinary rehabilitation (including
functional restoration training).
Comparators:
[cir] For all Key Questions, subquestion ``a''.
[ssquf] Sham treatment.
[ssquf] Waitlist.
[ssquf] Usual care.
[ssquf] Attention control.
[ssquf] No treatment.
[cir] For all Key Questions, subquestion ``b''.
[ssquf] Common nonopioid pharmacologic therapy used for chronic
pain (NSAIDs, acetaminophen, antiseizure medications, antidepressants,
muscle relaxants (including benzodiazepines) topical
agents,(diclofenac, lidocaine capsaicin).
[ssquf] Medical marijuana (any formulation).
[ssquf] Opioid analgesics.
[cir] Key Questions 1-4, 6, subquestion ``c'': Exercise.
[cir] Key Question 5, 6, subquestion ``c'': Biofeedback.
Outcomes:
[cir] Primary efficacy outcomes (in priority order); we will focus
on outcomes from validated measures.
[ssquf] Function/disability/pain interference.
[ssquf] Pain.
[cir] Harms and adverse effects.
[cir] Secondary outcomes.
[ssquf] Psychological distress (including depression and anxiety).
[ssquf] Quality of life.
[ssquf] Opioid use.
[ssquf] Sleep quality, sleep disturbance.
[ssquf] Health care utilization.
Timing:
[cir] Duration of followup: short term (up to 6 months),
intermediate term (6-12 months) and long term (at least 1 year); we
will focus on longer-term (>1 year) effects where possible.
[cir] Studies with <1 month followup after treatment will be
excluded.
Settings:
[cir] Any nonhospital setting or setting of self-directed care.
[cir] Exclusions: Hospital care, hospice care, emergency department
care.
Gopal Khanna,
Director.
[FR Doc. 2019-05143 Filed 3-18-19; 8:45 am]
BILLING CODE 4160-90-P
