Supplemental Evidence and Data Request on Drug Therapy for Early Rheumatoid Arthritis in Adults-An Update, 29083-29085 [2017-13395]

Download as PDF Federal Register / Vol. 82, No. 122 / Tuesday, June 27, 2017 / Notices these priority populations are encouraged. Sharon B. Arnold, Deputy Director. [FR Doc. 2017–13396 Filed 6–26–17; 8:45 am] BILLING CODE 4160–90–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Meeting of the National Advisory Council for Healthcare Research and Quality Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Notice of public meeting. AGENCY: In accordance with the Federal Advisory Committee Act, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality. DATES: The meeting will be held on Wednesday, July 26, 2017, from 8:30 a.m. to 2:45 p.m. ADDRESSES: The meeting will be held at AHRQ, 5600 Fishers Lane, Rockville, Maryland, 20857. FOR FURTHER INFORMATION CONTACT: Jaime Zimmerman, Designated Management Official, at the Agency for Healthcare Research and Quality, 5600 Fishers Lane, Mail Stop 06E37A, Rockville, Maryland 20857, (301) 427– 1456. For press-related information, please contact Alison Hunt at (301) 427– 1244 or Alison.Hunt@ahrq.hhs.gov. If sign language interpretation or other reasonable accommodation for a disability is needed, please contact the Food and Drug Administration (FDA) Office of Equal Employment Opportunity and Diversity Management on (301) 827–4840, no later than Wednesday, July 19, 2017. The agenda, roster, and minutes will be available from Ms. Bonnie Campbell, Committee Management Officer, Agency for Healthcare Research and Quality, 5600 Fishers Lane, Rockville, Maryland 20857. Ms. Campbell’s phone number is (301) 427–1554. SUPPLEMENTARY INFORMATION: SUMMARY: mstockstill on DSK30JT082PROD with NOTICES I. Purpose The National Advisory Council for Healthcare Research and Quality is authorized by Section 941 of the Public Health Service Act, 42 U.S.C. 299c. In accordance with its statutory mandate, the Council is to advise the Secretary of the Department of Health and Human Services and the Director of AHRQ on VerDate Sep<11>2014 18:33 Jun 26, 2017 Jkt 241001 matters related to AHRQ’s conduct of its mission including providing guidance on (A) priorities for health care research, (B) the field of health care research including training needs and information dissemination on health care quality and (C) the role of the Agency in light of private sector activity and opportunities for public private partnerships. The Council is composed of members of the public, appointed by the Secretary, and Federal ex-officio members specified in the authorizing legislation. II. Agenda On Wednesday, July 26, 2017, there will be a subcommittee meeting for the National Healthcare Quality and Disparities Report scheduled to begin at 7:30 a.m. This meeting is open to the public. The Council meeting will convene at 8:30 a.m., with the call to order by the Council Chair and approval of previous Council summary notes. The meeting is open to the public and will be available via webcast at www.webconferences.com/ahrq. The meeting will begin with an update on AHRQ’s current research, programs, and initiatives. The agenda will also include an update on AHRQ’s work in learning health care systems and AHRQ’s EvidenceNOW initiative, and will focus on the use of AHRQ data and analytics to answer emerging policy questions. The final agenda will be available on the AHRQ Web site at www.AHRQ.gov no later than Wednesday, July 19, 2017. Sharon B. Arnold, Deputy Director. [FR Doc. 2017–13393 Filed 6–26–17; 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 Drug Therapy for Early Rheumatoid Arthritis in Adults—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. Scientific information is being solicited to inform our review of Drug Therapy for Early Rheumatoid Arthritis in Adults—An Update, which is currently being conducted by the SUMMARY: PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 29083 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 July 27, 2017. ADDRESSES: Email submissions: SEADS@epc-src.org. Print submissions: Mailing Address: Portland VA Research Foundation, Scientific Resource Center, ATTN: Scientific Information Packet Coordinator, P.O. 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: AHRQ is conducting this systematic review pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a). The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for Drug Therapy for Early Rheumatoid Arthritis in Adults—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, 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 Drug Therapy for Early Rheumatoid Arthritis in Adults—An Update, including those that describe adverse events. The entire research protocol, including the key questions, is also available online at: https://effective healthcare.ahrq.gov/search-for-guidesreviews-and-reports/?pageaction= displayproduct&productID=2475. This is to notify the public that the EPC Program would find the following information on Drug Therapy for Early Rheumatoid Arthritis in Adults—An Update 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, E:\FR\FM\27JNN1.SGM 27JNN1 29084 Federal Register / Vol. 82, No. 122 / Tuesday, June 27, 2017 / Notices KQ 3 The Key Questions mstockstill on DSK30JT082PROD with NOTICES 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. 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 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. Exclusion Key Question (KQ) 1 For patients with early Rheumatoid Arthritis (RA), do drug therapies differ in their ability to reduce disease activity, slow or limit the progression of radiographic joint damage, or induce remission? Adolescents and adult patients with disease greater than 1 year from diagnosis. KQ 2 For patients with early RA, do drug therapies differ in their ability to improve patient-reported symptoms, functional capacity, or quality of life? VerDate Sep<11>2014 18:33 Jun 26, 2017 Jkt 241001 For patients with early RA, do drug therapies differ in harms, tolerability, patient adherence, or adverse effects? KQ 4 What are the comparative benefits and harms of drug therapies for early RA in subgroups of patients based on disease activity, prior therapy, demographics (e.g., women in their childbearing years), concomitant therapies, and presence of other serious conditions? C. TNF biologics: Adalimumab, certolizumab pegol, etanercept, golimumab, infliximab D. Non-TNF biologics: Abatacept, rituximab, tocilizumab E. tsDMARDs: Tofacitinib F. Biosimilars: Adalimumab-atto, infliximab-dyyb, infliximab-abda, etanercept-szzs II. Under review by FDA A. Non-TNF biologics: Sarilumab, sirukumab Exclusion Contextual Questions (CQs) Contextual questions are not systematically reviewed and use a ‘‘best evidence’’ approach. Information about the contextual questions may be included as part of the introduction or discussion section and related as appropriate to the Systematic Review. Anakinra is excluded because, although it is approved for RA, clinically it is not used anymore for this population. CQ 1 PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, Settings) I. For head-to-head RCTs, head-to-head nRCTs, and prospective, controlled cohort studies (all KQs): Any active intervention listed above II. For additional observational studies of harms (i.e., overall [KQ 3] and among subgroups [KQ 4]: Any active intervention listed above or no comparator (e.g., postmarketing surveillance study of an active intervention with no comparison group) III. For double-blinded, placebocontrolled trials for network metaanalysis (all KQs): Placebo Populations Exclusion Inclusion All other comparisons, including active interventions not listed above. Does treatment of early RA improve disease trajectory and disease outcomes compared with the trajectory or outcomes of treatment of established RA? CQ 2 What barriers prevent individuals with early RA from obtaining access to indicated drug therapies? I. All KQs: Adult outpatients ages 19 or older with an early RA diagnosis, defined as 1 year or less from disease diagnosis; we will include studies with mixed populations if >50% of study populations had an early RA diagnosis II. KQ 4 only: Subpopulations by age, sex/gender, race/ethnicity, disease activity, prior therapies, concomitant therapies, and other serious conditions Intervention/Exposure Comparator Inclusion Outcomes Inclusion I. KQs 1, 4: Disease activity, radiographic joint damage, remission II. KQs 2, 4: Functional capacity, quality of life, patient-reported symptoms III. KQs 3, 4: Overall risk of harms, overall discontinuation, discontinuation because of adverse effects, risk of serious adverse effects, specific adverse effects, patient adherence Exclusion All other outcomes not listed. Inclusion Timing I. FDA approved A. Corticosteroids: Methylprednisolone, prednisone, prednisolone B. csDMARDs: Hydroxychloroquine, leflunomide, methotrexate, sulfasalazine Inclusion PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 All KQs: At least 3 months of treatment. Exclusion <3 months treatment. E:\FR\FM\27JNN1.SGM 27JNN1 Federal Register / Vol. 82, No. 122 / Tuesday, June 27, 2017 / Notices Settings Inclusion All KQs: Outpatients. Exclusion Inpatients. Country Setting Inclusion All KQs: Any geographic area. Exclusion None. Study Designs Inclusion I. For all KQs (i.e., benefits and harms overall [KQs 1, 2, 3] and among subgroups [KQ 4]), we will include head-to head RCTs and nRCTs; prospective, controlled cohort studies (N ≥ 100); double-blinded, placebo-controlled trials for network meta-analysis; and SRs for identification of additional references only. II. For studies of harms (i.e., overall [KQ 3] and among subgroups [KQ 4]), we will also include any other observational study (e.g., cohort, case-control, large case series, post marketing surveillance) (N ≥ 100). Exclusion All other designs not listed. Publication Language Inclusion All KQs: English. Exclusion Languages other than English. Sharon B. Arnold, Deputy Director. [FR Doc. 2017–13395 Filed 6–26–17; 8:45 am] BILLING CODE 4160–90–P DEPARTMENT OF HEALTH AND HUMAN SERVICES mstockstill on DSK30JT082PROD with NOTICES Agency for Healthcare Research and Quality Supplemental Evidence and Data Request on Psychological and Pharmacological Treatments for Adults With Posttraumatic Stress Disorder (PTSD): A Systematic Review 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 SUMMARY: VerDate Sep<11>2014 18:33 Jun 26, 2017 Jkt 241001 scientific information submissions from the public. Scientific information is being solicited to inform our review of Psychological and Pharmacological Treatments for Adults with Posttraumatic Stress Disorder (PTSD): A Systematic Review Update, 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 July 27, 2017. ADDRESSES: Email submissions: SEADS@epcsrc.org. Print submissions: Mailing Address: Portland VA Research Foundation, Scientific Resource Center, ATTN: Scientific Information Packet Coordinator, P.O. 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 Psychological and Pharmacological Treatments for Adults with Posttraumatic Stress Disorder (PTSD): A Systematic Review Update. 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 Psychological and Pharmacological Treatments for Adults with Posttraumatic Stress Disorder (PTSD): A Systematic Review Update, including those that describe adverse events. The entire research protocol, including the key questions, is also available online at: https:// effectivehealthcare.ahrq.gov/index.cfm/ search-for-guides-reviews-and-reports/? PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 29085 pageaction=displayproduct& productid=2478. This is to notify the public that the EPC Program would find helpful the following information on Psychological and Pharmacological Treatments for Adults with Posttraumatic Stress Disorder (PTSD): A Systematic Review Update: 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 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 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://www.effectivehealthcare. ahrq.gov/index.cfm/join-theemail-list1/. The systematic review will answer the following questions. This information is E:\FR\FM\27JNN1.SGM 27JNN1

Agencies

[Federal Register Volume 82, Number 122 (Tuesday, June 27, 2017)]
[Notices]
[Pages 29083-29085]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13395]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Drug Therapy for Early 
Rheumatoid Arthritis in Adults--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. Scientific 
information is being solicited to inform our review of Drug Therapy for 
Early Rheumatoid Arthritis in Adults--An Update, 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 July 27, 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, P.O. 
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: AHRQ is conducting this systematic review 
pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 
299a(a). The Agency for Healthcare Research and Quality has 
commissioned the Evidence-based Practice Centers (EPC) Program to 
complete a review of the evidence for Drug Therapy for Early Rheumatoid 
Arthritis in Adults--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, 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 Drug Therapy for Early Rheumatoid Arthritis in Adults--
An Update, including those that describe adverse events. The entire 
research protocol, including the key questions, is also available 
online at: https://effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=2475.
    This is to notify the public that the EPC Program would find the 
following information on Drug Therapy for Early Rheumatoid Arthritis in 
Adults--An Update 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,

[[Page 29084]]

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. 
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 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

Key Question (KQ) 1

    For patients with early Rheumatoid Arthritis (RA), do drug 
therapies differ in their ability to reduce disease activity, slow or 
limit the progression of radiographic joint damage, or induce 
remission?

KQ 2

    For patients with early RA, do drug therapies differ in their 
ability to improve patient-reported symptoms, functional capacity, or 
quality of life?

KQ 3

    For patients with early RA, do drug therapies differ in harms, 
tolerability, patient adherence, or adverse effects?

KQ 4

    What are the comparative benefits and harms of drug therapies for 
early RA in subgroups of patients based on disease activity, prior 
therapy, demographics (e.g., women in their childbearing years), 
concomitant therapies, and presence of other serious conditions?

Contextual Questions (CQs)

    Contextual questions are not systematically reviewed and use a 
``best evidence'' approach. Information about the contextual questions 
may be included as part of the introduction or discussion section and 
related as appropriate to the Systematic Review.

CQ 1

    Does treatment of early RA improve disease trajectory and disease 
outcomes compared with the trajectory or outcomes of treatment of 
established RA?

CQ 2

    What barriers prevent individuals with early RA from obtaining 
access to indicated drug therapies?

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

Populations

Inclusion
I. All KQs: Adult outpatients ages 19 or older with an early RA 
diagnosis, defined as 1 year or less from disease diagnosis; we will 
include studies with mixed populations if >50% of study populations had 
an early RA diagnosis
II. KQ 4 only: Subpopulations by age, sex/gender, race/ethnicity, 
disease activity, prior therapies, concomitant therapies, and other 
serious conditions
Exclusion
    Adolescents and adult patients with disease greater than 1 year 
from diagnosis.

Intervention/Exposure

Inclusion
I. FDA approved
    A. Corticosteroids: Methylprednisolone, prednisone, prednisolone
    B. csDMARDs: Hydroxychloroquine, leflunomide, methotrexate, 
sulfasalazine
    C. TNF biologics: Adalimumab, certolizumab pegol, etanercept, 
golimumab, infliximab
    D. Non-TNF biologics: Abatacept, rituximab, tocilizumab
    E. tsDMARDs: Tofacitinib
    F. Biosimilars: Adalimumab-atto, infliximab-dyyb, infliximab-abda, 
etanercept-szzs
II. Under review by FDA
    A. Non-TNF biologics: Sarilumab, sirukumab
Exclusion
    Anakinra is excluded because, although it is approved for RA, 
clinically it is not used anymore for this population.

Comparator

Inclusion
I. For head-to-head RCTs, head-to-head nRCTs, and prospective, 
controlled cohort studies (all KQs): Any active intervention listed 
above
II. For additional observational studies of harms (i.e., overall [KQ 3] 
and among subgroups [KQ 4]: Any active intervention listed above or no 
comparator (e.g., postmarketing surveillance study of an active 
intervention with no comparison group)
III. For double-blinded, placebo-controlled trials for network meta-
analysis (all KQs): Placebo
Exclusion
    All other comparisons, including active interventions not listed 
above.

Outcomes

Inclusion
I. KQs 1, 4: Disease activity, radiographic joint damage, remission
II. KQs 2, 4: Functional capacity, quality of life, patient-reported 
symptoms
III. KQs 3, 4: Overall risk of harms, overall discontinuation, 
discontinuation because of adverse effects, risk of serious adverse 
effects, specific adverse effects, patient adherence
Exclusion
    All other outcomes not listed.

Timing

Inclusion
    All KQs: At least 3 months of treatment.
Exclusion
    <3 months treatment.

[[Page 29085]]

Settings

Inclusion
    All KQs: Outpatients.
Exclusion
    Inpatients.

Country Setting

Inclusion
    All KQs: Any geographic area.
Exclusion
    None.

Study Designs

Inclusion
I. For all KQs (i.e., benefits and harms overall [KQs 1, 2, 3] and 
among subgroups [KQ 4]), we will include head-to head RCTs and nRCTs; 
prospective, controlled cohort studies (N >= 100); double-blinded, 
placebo-controlled trials for network meta-analysis; and SRs for 
identification of additional references only.
II. For studies of harms (i.e., overall [KQ 3] and among subgroups [KQ 
4]), we will also include any other observational study (e.g., cohort, 
case-control, large case series, post marketing surveillance) (N >= 
100).
Exclusion
    All other designs not listed.

Publication Language

Inclusion
    All KQs: English.
Exclusion
    Languages other than English.

Sharon B. Arnold,
Deputy Director.
[FR Doc. 2017-13395 Filed 6-26-17; 8:45 am]
 BILLING CODE 4160-90-P