Supplemental Evidence and Data Request on Noninvasive, Nonpharmacological Treatment for Chronic Pain, 22826-22828 [2017-10067]

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[FR Doc. 2017–10069 Filed 5–17–17; 8:45 am] BILLING CODE 6210–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Supplemental Evidence and Data Request on Noninvasive, Nonpharmacological Treatment for Chronic Pain Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for supplemental evidence and data submissions. AGENCY: 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 of Noninvasive, Nonpharmacological SUMMARY: E:\FR\FM\18MYN1.SGM 18MYN1 jstallworth on DSK7TPTVN1PROD with NOTICES Federal Register / Vol. 82, No. 95 / Thursday, May 18, 2017 / Notices 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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 June 19, 2017. ADDRESSES: Email submissions: SEADS@epc-src.org. Print submissions: Mailing Address: Portland VA Research Foundation, Scientific Resource Center, ATTN: Scientific Information Packet Coordinator, PO Box 69539, Portland, OR 97239. Shipping Address (FedEx, UPS, etc.): Portland VA Research Foundation, Scientific Resource Center, ATTN: Scientific Information Packet Coordinator, 3710 SW U.S. Veterans Hospital Road, Mail Code: R&D 71, Portland, OR 97239. FOR FURTHER INFORMATION CONTACT: Ryan McKenna, Telephone: 503–220– 8262 ext. 51723 or Email: SEADS@epcsrc.org. 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, Nonpharmacological 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, Nonpharmacological Treatment for Chronic Pain, including those that describe adverse events. The entire research protocol, including the key questions, is also available online at: https://www.effective healthcare.ahrq.gov/search-for-guidesreviews-and-reports/?pageaction= displayproduct&productID=2470. This is to notify the public that the EPC Program would find the following information on Noninvasive, Nonpharmacological 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 VerDate Sep<11>2014 13:43 May 17, 2017 Jkt 241001 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 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. The contents of all submissions will be made available to the public upon request. 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 Web site 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 EPC email list at: https://www.effective healthcare.ahrq.gov/index.cfm/join-theemail-list1/. 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 I. In adults with chronic low back pain: A. What are the benefits and harms of noninvasive nonpharmacological therapies compared with sham PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 22827 treatment, no treatment, waitlist, attention control, or usual care? B. What are the benefits and harms of noninvasive nonpharmacological therapies compared with pharmacological therapy (e.g., opioids, NSAIDS, acetaminophen, anti-seizure medications, antidepressants)? C. What are the benefits and harms of noninvasive nonpharmacological therapies compared with exercise? II. In adults with chronic neck pain: A. What are the benefits and harms of noninvasive nonpharmacological therapies compared with sham treatment, no treatment, waitlist, attention control, or usual care? B. What are the benefits and harms of noninvasive nonpharmacological therapies compared with pharmacological therapy? C. What are the benefits and harms of noninvasive nonpharmacological therapies compared with exercise? III. In adults with osteoarthritisrelated pain: A. What are the benefits and harms of noninvasive nonpharmacological therapies compared with sham treatment, no treatment, waitlist, attention control, or usual care? B. What are the benefits and harms of noninvasive nonpharmacological therapies compared with pharmacological therapy? C. What are the benefits and harms of noninvasive nonpharmacological therapies compared with exercise? IV. In adults with fibromyalgia: A. What are the benefits and harms of noninvasive nonpharmacological therapies compared with sham treatment, no treatment, waitlist, attention control, or usual care? B. What are the benefits and harms of noninvasive nonpharmacological therapies compared with pharmacological therapy? C. What are the benefits and harms of noninvasive nonpharmacological therapies compared with exercise? V. In adults with chronic tension headache: A. What are the benefits and harms of noninvasive nonpharmacological therapies compared with sham treatment, no treatment, waitlist, attention control, or usual care? B. What are the benefits and harms of noninvasive nonpharmacological therapies compared with pharmacological therapy? C. What are the benefits and harms of noninvasive nonpharmacological therapies compared with biofeedback? VI. Do estimates of benefits and harms differ by age, sex, or presence of comorbidities (e.g., emotional or mood disorders)? E:\FR\FM\18MYN1.SGM 18MYN1 22828 Federal Register / Vol. 82, No. 95 / Thursday, May 18, 2017 / Notices C. Opioid use D. Sleep quality, sleep disturbance E. Health care utilization PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, Settings) Population(s): Adults 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: Key Question 1: Nonradicular chronic low back pain Key Question 2: Chronic neck pain without radiculopathy or myelopathy Key Question 3: Pain related to primary or secondary osteoarthritis Key Question 4: Fibromyalgia Key Question 5: Primary chronic tension headache (defined as 15 or more headache days per month for at least 3 months) Key Question 6: Patients with any of the five chronic pain conditions Timing I. 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 longerterm (>1 year) effects where possible II. Studies with <1 month followup after treatment will be excluded Settings I. Any nonhospital setting or setting of self-directed care II. Exclusions: Hospital care, hospice care, emergency department care Sharon B. Arnold, Deputy Director. [FR Doc. 2017–10067 Filed 5–17–17; 8:45 am] BILLING CODE 4160–90–P Interventions (All Key Questions) I. Exercise II. Psychological therapies III. Physical modalities IV. Manual therapies V. Mindfulness practices VI. Mind-body practices VII. Acupuncture VIII. Functional restoration training IX. Multidisciplinary/interdisciplinary rehabilitation Comparators I. For all Key Questions, subquestion ‘‘a’’ A. Sham treatment B. Waitlist C. Usual care D. Attention control E. No treatment II. For all Key Questions, subquestion ‘‘b’’ A. Non-opioid pharmacological therapy (nonsteroidal antiinflammatory drugs, acetaminophen, antiseizure medications, antidepressants) B. Opioid analgesics III. Key Questions 1–4, 6, subquestion ‘‘c’’: Exercise IV. Key Question 5, 6, subquestion ‘‘c’’: Biofeedback jstallworth on DSK7TPTVN1PROD with NOTICES Outcomes I. Primary efficacy outcomes (in priority order); we will focus on outcomes from validated measures A. Function/disability/pain interference B. Pain II. Harms and adverse effects III. Secondary outcomes A. Psychological distress (including depression and anxiety) B. Quality of life VerDate Sep<11>2014 13:43 May 17, 2017 Jkt 241001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request Agency for Healthcare Research and Quality, HHS. ACTION: Notice. AGENCY: This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ‘‘TeamSTEPPS 2.0 Online Master Trainer Course.’’ DATES: Comments on this notice must be received by July 17, 2017. ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email at doris.lefkowitz@ahrq.hhs.gov. Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer. FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427–1477, or by email at doris.lefkowitz@ahrq.hhs.gov. SUPPLEMENTARY INFORMATION: SUMMARY: Proposed Project TeamSTEPPS 2.0 Online Master Trainer Course In accordance with the Paperwork Reduction Act of 1995, Public Law 104– PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection. As part of its effort to fulfill its mission goals, AHRQ, in collaboration with the U.S. Department of Defense’s TRICARE Management Activity, developed TeamSTEPPS® (Team Strategies and Tools for Enhancing Performance and Patient Safety) to provide an evidencebased suite of tools and strategies for training teamwork-based patient safety to health care professionals. TeamSTEPPS includes multiple toolkits, which are all tied to, or are variants of, the core curriculum. TeamSTEPPS resources have been developed for primary care, rapid response systems, long-term care, and patients with limited English proficiency. The main objective of the TeamSTEPPS program is to improve patient safety by training health care staff in various teamwork, communication, and patient safety concepts, tools, and techniques and ultimately helping to build national capacity for supporting teamwork-based patient safety efforts in health care organizations. Created in 2007, AHRQ’s National Implementation Program trains Master Trainers who have stimulated the use and adoption of TeamSTEPPS in health care delivery systems. These individuals were trained during two-day, in-person classes using the TeamSTEPPS core curriculum at regional training centers across the U.S. AHRQ has also provided technical assistance and consultation on implementing TeamSTEPPS and has developed user networks, various educational venues, and other channel of learning for continued support and the improvement of teamwork in health care. Since the inception of the National Implementation Program, AHRQ has trained more than 6,000 participants to serve as TeamSTEPPS Master Trainers. Due to the success of the National Implementation Program, which resulted in increased requests for inperson training, AHRQ had been unable to match the demand for TeamSTEPPS Master Training, and wait lists for training at times exceeded 500 individuals. To address this prevailing need, AHRQ developed TeamSTEPPS 2.0 Online Master Trainer course, which mirrors the TeamSTEPPS 2.0 core curriculum and provides equivalent training to the in-person classes offered through the National Implementation Program. As part of this initiative, AHRQ seeks to continue to conduct an evaluation of the TeamSTEPPS 2.0 Online Master E:\FR\FM\18MYN1.SGM 18MYN1

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[Federal Register Volume 82, Number 95 (Thursday, May 18, 2017)]
[Notices]
[Pages 22826-22828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10067]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Noninvasive, 
Nonpharmacological 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 of Noninvasive, 
Nonpharmacological

[[Page 22827]]

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 June 19, 2017.

ADDRESSES: Email submissions: src.org">SEADS@epc-src.org.
    Print submissions:
    Mailing Address: Portland VA Research Foundation, Scientific 
Resource Center, ATTN: Scientific Information Packet Coordinator, PO 
Box 69539, Portland, OR 97239.
    Shipping Address (FedEx, UPS, etc.): Portland VA Research 
Foundation, Scientific Resource Center, ATTN: Scientific Information 
Packet Coordinator, 3710 SW U.S. Veterans Hospital Road, Mail Code: R&D 
71, Portland, OR 97239.

FOR FURTHER INFORMATION CONTACT: Ryan McKenna, Telephone: 503-220-8262 
ext. 51723 or Email: src.org">SEADS@epc-src.org.

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, 
Nonpharmacological 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, Nonpharmacological Treatment for Chronic 
Pain, including those that describe adverse events. The entire research 
protocol, including the key questions, is also available online at: 
https://www.effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=2470.
    This is to notify the public that the EPC Program would find the 
following information on Noninvasive, Nonpharmacological 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 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. The 
contents of all submissions will be made available to the public upon 
request. 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 Web 
site 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 EPC email list at: https://www.effectivehealthcare.ahrq.gov/index.cfm/join-the-email-list1/.
    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

    I. In adults with chronic low back pain:
    A. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with sham treatment, no 
treatment, waitlist, attention control, or usual care?
    B. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with pharmacological therapy 
(e.g., opioids, NSAIDS, acetaminophen, anti-seizure medications, 
antidepressants)?
    C. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with exercise?
    II. In adults with chronic neck pain:
    A. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with sham treatment, no 
treatment, waitlist, attention control, or usual care?
    B. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with pharmacological therapy?
    C. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with exercise?
    III. In adults with osteoarthritis-related pain:
    A. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with sham treatment, no 
treatment, waitlist, attention control, or usual care?
    B. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with pharmacological therapy?
    C. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with exercise?
    IV. In adults with fibromyalgia:
    A. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with sham treatment, no 
treatment, waitlist, attention control, or usual care?
    B. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with pharmacological therapy?
    C. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with exercise?
    V. In adults with chronic tension headache:
    A. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with sham treatment, no 
treatment, waitlist, attention control, or usual care?
    B. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with pharmacological therapy?
    C. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with biofeedback?
    VI. Do estimates of benefits and harms differ by age, sex, or 
presence of comorbidities (e.g., emotional or mood disorders)?

[[Page 22828]]

PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, 
Settings)

Population(s): Adults 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:

Key Question 1: Nonradicular chronic low back pain
Key Question 2: Chronic neck pain without radiculopathy or myelopathy
Key Question 3: Pain related to primary or secondary osteoarthritis
Key Question 4: Fibromyalgia
Key Question 5: Primary chronic tension headache (defined as 15 or more 
headache days per month for at least 3 months)
Key Question 6: Patients with any of the five chronic pain conditions

Interventions (All Key Questions)

I. Exercise
II. Psychological therapies
III. Physical modalities
IV. Manual therapies
V. Mindfulness practices
VI. Mind-body practices
VII. Acupuncture
VIII. Functional restoration training
IX. Multidisciplinary/interdisciplinary rehabilitation

Comparators

I. For all Key Questions, subquestion ``a''
    A. Sham treatment
    B. Waitlist
    C. Usual care
    D. Attention control
    E. No treatment
II. For all Key Questions, subquestion ``b''
    A. Non-opioid pharmacological therapy (nonsteroidal anti-
inflammatory drugs, acetaminophen, antiseizure medications, 
antidepressants)
    B. Opioid analgesics
III. Key Questions 1-4, 6, subquestion ``c'': Exercise
IV. Key Question 5, 6, subquestion ``c'': Biofeedback

Outcomes

I. Primary efficacy outcomes (in priority order); we will focus on 
outcomes from validated measures
    A. Function/disability/pain interference
    B. Pain
II. Harms and adverse effects
III. Secondary outcomes
    A. Psychological distress (including depression and anxiety)
    B. Quality of life
    C. Opioid use
    D. Sleep quality, sleep disturbance
    E. Health care utilization

Timing

I. 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
II. Studies with <1 month followup after treatment will be excluded

Settings

I. Any nonhospital setting or setting of self-directed care
II. Exclusions: Hospital care, hospice care, emergency department care

Sharon B. Arnold,
Deputy Director.
[FR Doc. 2017-10067 Filed 5-17-17; 8:45 am]
 BILLING CODE 4160-90-P

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