Supplemental Evidence and Data Request on Noninvasive Nonpharmacologic Treatment for Chronic Pain, 10087-10088 [2019-05143]

Download as PDF 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