Supplemental Evidence and Data for Systematic Reviews Request on Osteoarthritis of the Knee: An Update, 45502-45504 [2016-16632]

Download as PDF 45502 Federal Register / Vol. 81, No. 135 / Thursday, July 14, 2016 / Notices DEPARTMENT OF DEFENSE GENERAL SERVICES ADMINISTRATION NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [OMB Control No. 9000–0114; Docket 2016– 0053; Sequence 23] Submission for OMB Review; Right of First Refusal of Employment Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA). ACTION: Notice of request for public comments regarding an extension to an existing OMB clearance. AGENCY: Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection. SUMMARY: Submit comments on or before August 15, 2016. ADDRESSES: Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington, DC 20503. Additionally submit a copy to GSA by any of the following methods: • Regulations.gov: http:// www.regulations.gov. Submit comments via the Federal eRulemaking portal by searching the OMB control number. Select the link ‘‘Submit a Comment’’ that corresponds with ‘‘Information Collection 9000–0114, Right of First Refusal of Employment’’. Follow the instructions provided at the ‘‘Submit a Comment’’ screen. Please include your name, company name (if any), and ‘‘Information Collection 9000–0114, Right of First Refusal of Employment’’ on your attached document. • Mail: General Services Administration, Regulatory Secretariat Divison (MVCB), 1800 F Street NW., Washington, DC 20405. ATTN: Ms. Flowers/IC 9000–0114, Right of First Refusal of Employment. Instructions: Please submit comments only and cite Information Collection 9000–0114, Right of First Refusal of Employment, in all correspondence related to this collection. Comments received generally will be posted without change to http:// asabaliauskas on DSK3SPTVN1PROD with NOTICES DATES: VerDate Sep<11>2014 19:33 Jul 13, 2016 Jkt 238001 www.regulations.gov, including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please check www.regulations.gov, approximately two to three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail). FOR FURTHER INFORMATION CONTACT: Mr. Michael O. Jackson, Procurement Analyst, Office of Governmentwide Acquisition Policy, GSA, at 202–208– 4949 or via email at michaelo.jackson@ gsa.gov. SUPPLEMENTARY INFORMATION: A. Purpose As prescribed in FAR 7.305(c), the clause at FAR 52.207–3, Right of First Refusal of Employment, deals with adversely affected or separated Government employees resulting from the conversion of work from in-house performance to performance by contract. The clause requires the contractor to give these employees an opportunity to work for the contractor who is awarded the contract. The information gathered will be used by the Government to gain knowledge of which employees, adversely affected or separated as a result of the contract award, have gained employment with the contractor within 90 days after contract performance begins. A notice was published in the Federal Register at 81 FR 19606 on April 5, 2016. No comments were received. B. Annual Reporting Burden Number of Respondents: 10. Responses per Respondent: 1. Total Responses: 10. Hours per Response: 3. Total Burden Hours: 30. Frequency of Collection: On occasion. Affected Public: Businesses or other for-profit and not-for profit organizations. Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202–501–4755. Please cite OMB Control No. 9000–0114, Right of First Refusal of Employment, in all correspondence. Dated: July 11, 2016. Kathlyn Hopkins, Acting Director, Federal Acquisition Policy Division, Office of Governmentwide Acquisition Policy, Office of Acquisition Policy, Office of Governmentwide Policy. [FR Doc. 2016–16685 Filed 7–13–16; 8:45 am] BILLING CODE 6820–EP–P PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Supplemental Evidence and Data for Systematic Reviews Request on Osteoarthritis of the Knee: An Update 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. Supplemental datasets are being solicited to inform the review of Osteoarthritis of the Knee: An Update, which is currently being conducted by AHRQ’s Evidence-based Practice Centers (EPC) Programs. Obtaining access to published and unpublished pertinent scientific information will improve the quality of this review. AHRQ is conducting this systematic review pursuant to section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a). SUMMARY: Submission Deadline on or before August 15, 2016. ADDRESSES: Email submissions: SEADS@epcsrc.org. Print submissions: Mailing Address: Portland VA Research Foundation, Scientific Resource Center, ATTN: SEADS Coordinator, P.O. Box 69539, Portland, OR 97239. Shipping Address (FedEx, UPS, etc.): Portland VA Research Foundation, Scientific Resource Center, ATTN: SEADS 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 its Evidencebased Practice Centers (EPC) Programs to complete a review of the evidence a review that updates information on treatments for osteoarthritis of the knee. The review will be titled Osteoarthritis of the Knee: An Update. 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, AHRQ is supplementing the usual manual and electronic database searches of the literature by requesting DATES: E:\FR\FM\14JYN1.SGM 14JYN1 asabaliauskas on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 81, No. 135 / Thursday, July 14, 2016 / Notices information (e.g., details of studies conducted) from the public. We are looking for studies that report on treatments for osteoarthritis of the knee, 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-guides-reviews-and-reports/ ?pageaction=displayproduct &productID=2247. This notice is to notify the public that the EPC program would find the following information on treatments for osteoarthritis of the knee 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 organization for this indication and an index outlining the relevant information in each submitted file. Your contribution is 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 could 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 VerDate Sep<11>2014 19:33 Jul 13, 2016 Jkt 238001 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://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 entire research protocol, is available online at: https://www.effective healthcare.ahrq.gov/search-for-guidesreviews-and-reports/?pageaction= displayproduct&productID=2247 Key Questions Key Question 1 I. What is the clinical effectiveness of oral glucosamine and/or chondroitin, physical treatments, weight loss, oral serotoninnorepinephrine reuptake inhibitors (SNRIs), intraarticular corticosteroids and/or prolotherapy, topical or transdermal analgesics, acupuncture, or cell-based therapies in patients with primary or secondary OA of the knee, compared with appropriate placebo/sham controls or compared with other active interventions? II. How do the outcomes of each intervention differ by the following population and study characteristics: Sex, disease subtype (lateral, patellofemoral), severity (stage/baseline pain and functional status), weight status (body mass index), baseline fitness (activity level), comorbidities, prior or concurrent treatments (including self-initiated therapies), and treatment duration or intensity? Key Question 2 I. What harms are associated with each intervention in patients with primary or secondary OA of the knee? II. How do the harms associated with each intervention differ by the following population or study characteristics: Sex, disease subtype (lateral tibiofemoral, patellofemoral), severity (stage/ baseline pain and functional status), weight status (body mass index), baseline fitness (activity level), comorbidities, prior or concurrent treatments (including self-initiated therapies), and treatment duration or intensity? PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 45503 PICOTS (Population, Intervention, Comparator, Outcome, Timing, Setting) Population(s) I. Adults (age 18 or over) with a diagnosis of primary (or secondary) OA of the knee, as defined by the American Academy of Orthopaedic Surgeons (AAOS, 2013), ACR clinical classification criteria, or Kellgren-Lawrence stage. II. Subpopulations of interest include those defined by sex, disease subtype (e.g., patellofemoral, or medial tibiofemoral), disease severity (stage/pain or functional status), body mass index, fitness/ activity level, prior treatment, concurrent treatment(s), comorbidities III. Exclusions: A. Studies of individuals under age 18; those with OA caused by a congenital condition; and those with OA concomitant with a meniscal or anterior cruciate ligament tear will be excluded because these participants have conditions that differ importantly from the vast majority of OA patients B. Studies that include those who have had knee replacement surgery on the affected limb or for whom outcomes will be measured after knee replacement surgery or who have concomitant joint disease such as rheumatoid arthritis or gout will be excluded because these conditions or procedures will confound assessment of the outcomes of interventions. C. If three or more RCTs of a particular intervention are included that enroll at least 50 participants per study arm, smaller studies of the same intervention will be excluded unless they report on a subgroup analysis of interest because studies on management of OA of the knee that enroll fewer than 50 participants per study arm have been shown to have high risk of bias and significantly larger effect sizes. Interventions I. Pharmacologic treatments A. Oral agents i. Glucosamine and/or chondroitin ii. SNRIs (to be assessed for review in next update) B. Intra-articular injected agents (to be assessed for review in next update) i. Corticosteroids (to be assessed for review in next update) ii. Prolotherapeutic agents (e.g. dextrose) (to be reviewed in next update) E:\FR\FM\14JYN1.SGM 14JYN1 45504 Federal Register / Vol. 81, No. 135 / Thursday, July 14, 2016 / Notices iii. Hyaluronic acid (to be assessed for review in next update) C. Topical and transdermal agents (to be assessed for review in next update) i. Capsaicin (to be assessed for review in next update) ii. NSAIDs (to be assessed for review in next update) II. Cell-based therapies A. Platelet-rich plasma B. Intraarticular or arthroscopic administration of mesenchymal stem-cells or chondrocytes or tissue C. Exclusions: i. Phase I or II trials will not be included for efficacy, as the interventions are generally not FDA-approved for use. III. Physical treatments and/or weight loss A. Physical therapy and exercise programs i. Manual therapy ii. Land-based therapy and/or exercise iii. Exercise programs (aerobic, resistance) iv. Aquatherapy v. Balneotherapy, mud therapy vi. Heat or cold vii. Self-management programs B. Weight loss C. Braces or kinesiology taping D. Orthotic shoe inserts and/or wedges E. Vibrating platform F. Neuromuscular electrical stimulation (e.g., Transcutaneous electrical nerve stimulation) IV. Acupuncture (to be assessed for review in next update) A. Needle acupuncture alone (to be assessed for review in next update) B. Moxibustion (to be assessed for review in next update) V. Combination interventions (to be assessed for review in next update) A. Sequential treatment algorithms (to be assessed for review in next update) asabaliauskas on DSK3SPTVN1PROD with NOTICES Comparators I. Pharmacologic treatments: Placebocontrolled or head-to-head noninferiority only II. Cell-based therapies: Placebo- or sham-controlled only III. Physical treatments and/or weight loss: Placebo-controlled, usual carecontrolled, or wait list-controlled only except for weight loss IV. Neuromuscular electrical stimulation: Sham stimulation without current V. Wait list VI. Treatment as usual VII. Studies that use the untreated knee as a control will be excluded, based on evidence indicating that VerDate Sep<11>2014 19:33 Jul 13, 2016 Jkt 238001 individuals with OA in one knee are likely to have some, but not necessarily identically, reduced function in the other knee and that treatment of one knee only may improve pain in that knee but may not markedly improve function VIII. Studies that use participants as their own controls will be excluded, unless no randomized controlled trials are identified for a particular intervention of interest, as quasiexperimental designs provide weaker evidence. IX. Exclusions: A. Studies that use an active control that has not been established to be effective will be excluded. Efficacy and effectiveness must be established before examining comparative effectiveness questions. Outcomes I. Short-term clinical outcomes A. Pain (e.g., VAS, WOMAC, KOOS,) B. Joint stiffness (WOMAC) C. Function (WOMAC, Lequesne, others) D. OARSI physical outcomes (e.g., timed up-and-go, 6-minute walk test) E. Patient Reported Outcome Measurement System (PROMIS®) and Osteoarthritis-Computer Adaptive Test (OA–CAT) F. Inflammation or effusion G. Medication use II. Long-term clinical outcomes A. Any of the short-term clinical outcomes B. Instrumental activities of daily living (IADLs) C. Quality of life (e.g., SF–36, EuroQuol EQ–5D, Arthritis SelfEfficacy scale, global assessment, patient satisfaction) D. Surgery (i.e., rate of undergoing knee replacement) III. Adverse effects of intervention(s) IV. Outcome reporting A. Only studies that report outcomes for knee OA alone B. Mean differences at followup or percent of responders at followup will be abstracted Timing Minimum 1 month follow-up from initiation of treatment Settings Any setting Andrew B. Bindman, AHRQ Director. [FR Doc. 2016–16632 Filed 7–13–16; 8:45 am] BILLING CODE 4160–90–P PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Institute for Occupational Safety and Health (NIOSH), Safety and Occupational Health Study Section: Notice of Charter Renewal This gives notice under the Federal Advisory Committee Act (Pub. L. 92– 463) of October 6, 1972, that the Safety and Occupational Health Study Section, Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through June 30, 2018. For more information contact: JoAnne Fairbanks, Executive Secretary, Safety and Occupational Health Study Section, Department of Health and Human Services, 1600 Clifton Road NE., Mailstop E74, Atlanta, Georgia 30333, telephone 304/285–6143 or fax 304/ 285–6147. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Catherine Ramadei, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2016–16583 Filed 7–13–16; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Institute for Occupational Safety and Health (NIOSH), Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board) In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), and pursuant to the requirements of 42 CFR 83.15(a), the Centers for Disease Control and Prevention (CDC), announces the following meeting of the aforementioned committee: Times and Dates: 8:15 a.m.–5:00 p.m., Mountain Time, August 9, 2016; 8:15 a.m.–1:00 p.m., Mountain Time, August 10, 2016. Public Comment Time and Date: 5:00 p.m.–6:00 p.m.*, Mountain Time, August 9, 2016. E:\FR\FM\14JYN1.SGM 14JYN1

Agencies

[Federal Register Volume 81, Number 135 (Thursday, July 14, 2016)]
[Notices]
[Pages 45502-45504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16632]


=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data for Systematic Reviews Request on 
Osteoarthritis of the Knee: An Update

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. 
Supplemental datasets are being solicited to inform the review of 
Osteoarthritis of the Knee: An Update, which is currently being 
conducted by AHRQ's Evidence-based Practice Centers (EPC) Programs. 
Obtaining access to published and unpublished pertinent scientific 
information will improve the quality of this review. AHRQ is conducting 
this systematic review pursuant to section 902(a) of the Public Health 
Service Act, 42 U.S.C. 299a(a).

DATES: Submission Deadline on or before August 15, 2016.

ADDRESSES: 
    Email submissions: src.org">SEADS@epc-src.org.
    Print submissions:
    Mailing Address: Portland VA Research Foundation, Scientific 
Resource Center, ATTN: SEADS Coordinator, P.O. Box 69539, Portland, OR 
97239.
    Shipping Address (FedEx, UPS, etc.): Portland VA Research 
Foundation, Scientific Resource Center, ATTN: SEADS 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 its Evidence-based Practice Centers (EPC) 
Programs to complete a review of the evidence a review that updates 
information on treatments for osteoarthritis of the knee. The review 
will be titled Osteoarthritis of the Knee: An Update.
    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, AHRQ is supplementing the usual manual and electronic 
database searches of the literature by requesting

[[Page 45503]]

information (e.g., details of studies conducted) from the public. We 
are looking for studies that report on treatments for osteoarthritis of 
the knee, 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-guides-reviews-and-reports/?pageaction=displayproduct&productID=2247.
    This notice is to notify the public that the EPC program would find 
the following information on treatments for osteoarthritis of the knee 
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 is 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 could 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 email list at: https://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 entire research 
protocol, is available online at: https://www.effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=2247

Key Questions

Key Question 1

I. What is the clinical effectiveness of oral glucosamine and/or 
chondroitin, physical treatments, weight loss, oral serotonin-
norepinephrine reuptake inhibitors (SNRIs), intraarticular 
corticosteroids and/or prolotherapy, topical or transdermal analgesics, 
acupuncture, or cell-based therapies in patients with primary or 
secondary OA of the knee, compared with appropriate placebo/sham 
controls or compared with other active interventions?
II. How do the outcomes of each intervention differ by the following 
population and study characteristics: Sex, disease subtype (lateral, 
patellofemoral), severity (stage/baseline pain and functional status), 
weight status (body mass index), baseline fitness (activity level), 
comorbidities, prior or concurrent treatments (including self-initiated 
therapies), and treatment duration or intensity?

Key Question 2

I. What harms are associated with each intervention in patients with 
primary or secondary OA of the knee?
II. How do the harms associated with each intervention differ by the 
following population or study characteristics: Sex, disease subtype 
(lateral tibiofemoral, patellofemoral), severity (stage/baseline pain 
and functional status), weight status (body mass index), baseline 
fitness (activity level), comorbidities, prior or concurrent treatments 
(including self-initiated therapies), and treatment duration or 
intensity?

PICOTS (Population, Intervention, Comparator, Outcome, Timing, Setting)

Population(s)

I. Adults (age 18 or over) with a diagnosis of primary (or secondary) 
OA of the knee, as defined by the American Academy of Orthopaedic 
Surgeons (AAOS, 2013), ACR clinical classification criteria, or 
Kellgren-Lawrence stage.
II. Subpopulations of interest include those defined by sex, disease 
subtype (e.g., patellofemoral, or medial tibiofemoral), disease 
severity (stage/pain or functional status), body mass index, fitness/
activity level, prior treatment, concurrent treatment(s), comorbidities
III. Exclusions:
    A. Studies of individuals under age 18; those with OA caused by a 
congenital condition; and those with OA concomitant with a meniscal or 
anterior cruciate ligament tear will be excluded because these 
participants have conditions that differ importantly from the vast 
majority of OA patients
    B. Studies that include those who have had knee replacement surgery 
on the affected limb or for whom outcomes will be measured after knee 
replacement surgery or who have concomitant joint disease such as 
rheumatoid arthritis or gout will be excluded because these conditions 
or procedures will confound assessment of the outcomes of 
interventions.
    C. If three or more RCTs of a particular intervention are included 
that enroll at least 50 participants per study arm, smaller studies of 
the same intervention will be excluded unless they report on a subgroup 
analysis of interest because studies on management of OA of the knee 
that enroll fewer than 50 participants per study arm have been shown to 
have high risk of bias and significantly larger effect sizes.

Interventions

I. Pharmacologic treatments
    A. Oral agents
    i. Glucosamine and/or chondroitin
    ii. SNRIs (to be assessed for review in next update)
    B. Intra-articular injected agents (to be assessed for review in 
next update)
    i. Corticosteroids (to be assessed for review in next update)
    ii. Prolotherapeutic agents (e.g. dextrose) (to be reviewed in next 
update)

[[Page 45504]]

    iii. Hyaluronic acid (to be assessed for review in next update)
    C. Topical and transdermal agents (to be assessed for review in 
next update)
    i. Capsaicin (to be assessed for review in next update)
    ii. NSAIDs (to be assessed for review in next update)
II. Cell-based therapies
    A. Platelet-rich plasma
    B. Intraarticular or arthroscopic administration of mesenchymal 
stem-cells or chondrocytes or tissue
    C. Exclusions:
    i. Phase I or II trials will not be included for efficacy, as the 
interventions are generally not FDA-approved for use.
III. Physical treatments and/or weight loss
    A. Physical therapy and exercise programs
    i. Manual therapy
    ii. Land-based therapy and/or exercise
    iii. Exercise programs (aerobic, resistance)
    iv. Aquatherapy
    v. Balneotherapy, mud therapy
    vi. Heat or cold
    vii. Self-management programs
    B. Weight loss
    C. Braces or kinesiology taping
    D. Orthotic shoe inserts and/or wedges
    E. Vibrating platform
    F. Neuromuscular electrical stimulation (e.g., Transcutaneous 
electrical nerve stimulation)
IV. Acupuncture (to be assessed for review in next update)
    A. Needle acupuncture alone (to be assessed for review in next 
update)
    B. Moxibustion (to be assessed for review in next update)
V. Combination interventions (to be assessed for review in next update)
    A. Sequential treatment algorithms (to be assessed for review in 
next update)

Comparators

I. Pharmacologic treatments: Placebo-controlled or head-to-head non-
inferiority only
II. Cell-based therapies: Placebo- or sham-controlled only
III. Physical treatments and/or weight loss: Placebo-controlled, usual 
care-controlled, or wait list-controlled only except for weight loss
IV. Neuromuscular electrical stimulation: Sham stimulation without 
current
V. Wait list
VI. Treatment as usual
VII. Studies that use the untreated knee as a control will be excluded, 
based on evidence indicating that individuals with OA in one knee are 
likely to have some, but not necessarily identically, reduced function 
in the other knee and that treatment of one knee only may improve pain 
in that knee but may not markedly improve function
VIII. Studies that use participants as their own controls will be 
excluded, unless no randomized controlled trials are identified for a 
particular intervention of interest, as quasi-experimental designs 
provide weaker evidence.
IX. Exclusions:
    A. Studies that use an active control that has not been established 
to be effective will be excluded. Efficacy and effectiveness must be 
established before examining comparative effectiveness questions.

Outcomes

I. Short-term clinical outcomes
    A. Pain (e.g., VAS, WOMAC, KOOS,)
    B. Joint stiffness (WOMAC)
    C. Function (WOMAC, Lequesne, others)
    D. OARSI physical outcomes (e.g., timed up-and-go, 6-minute walk 
test)
    E. Patient Reported Outcome Measurement System (PROMIS[supreg]) and 
Osteoarthritis-Computer Adaptive Test (OA-CAT)
    F. Inflammation or effusion
    G. Medication use
II. Long-term clinical outcomes
    A. Any of the short-term clinical outcomes
    B. Instrumental activities of daily living (IADLs)
    C. Quality of life (e.g., SF-36, EuroQuol EQ-5D, Arthritis Self-
Efficacy scale, global assessment, patient satisfaction)
    D. Surgery (i.e., rate of undergoing knee replacement)
III. Adverse effects of intervention(s)
IV. Outcome reporting
    A. Only studies that report outcomes for knee OA alone
    B. Mean differences at followup or percent of responders at 
followup will be abstracted

Timing

Minimum 1 month follow-up from initiation of treatment

Settings

Any setting

Andrew B. Bindman,
AHRQ Director.
[FR Doc. 2016-16632 Filed 7-13-16; 8:45 am]
 BILLING CODE 4160-90-P