82_FR_32501 82 FR 32368 - Supplemental Evidence and Data Request on Stroke Prevention in Atrial Fibrillation Patients: A Systematic Review Update

82 FR 32368 - Supplemental Evidence and Data Request on Stroke Prevention in Atrial Fibrillation Patients: A Systematic Review Update

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality

Federal Register Volume 82, Issue 133 (July 13, 2017)

Page Range32368-32370
FR Document2017-14701

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 Stroke Prevention in Atrial Fibrillation Patients: 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.

Federal Register, Volume 82 Issue 133 (Thursday, July 13, 2017) 
[Federal Register Volume 82, Number 133 (Thursday, July 13, 2017)]
[Notices]
[Pages 32368-32370]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-14701]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Stroke Prevention in 
Atrial Fibrillation Patients: A Systematic Review 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 Stroke 
Prevention in Atrial Fibrillation Patients: 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 Access to published and unpublished 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 August 14, 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: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Centers (EPC) 
Program to complete a review of the evidence for Stroke Prevention in 
Atrial Fibrillation Patients: A Systematic Review Update. AHRQ is 
conducting

[[Page 32369]]

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 Stroke Prevention in Atrial Fibrillation Patients: 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/?pageaction=displayproduct&productid=2481.
    This is to notify the public that the EPC Program would find the 
following information on Stroke Prevention in Atrial Fibrillation 
Patients: A Systematic Review 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, 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/ 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 patients with nonvalvular atrial fibrillation, what are the 
comparative diagnostic accuracy and impact on clinical decision-making 
(diagnostic thinking, therapeutic and patient outcome efficacy) of 
available clinical and imaging tools and associated risk factors for 
predicting thromboembolic risk?
II. In patients with nonvalvular atrial fibrillation, what are the 
comparative diagnostic accuracy and impact on clinical decision-making 
(diagnostic thinking, therapeutic, and patient outcome efficacy) of 
clinical tools and associated risk factors for predicting bleeding 
events?
III. What are the comparative safety and effectiveness of specific 
anticoagulation therapies, antiplatelet therapies, and procedural 
interventions for preventing thromboembolic events:
    A. In patients with nonvalvular atrial fibrillation?
    B. In specific subpopulations of patients with nonvalvular atrial 
fibrillation?

Contextual Question

    What are currently available shared decision-making tools for 
patient and provider use for stroke prophylaxis in atrial fibrillation, 
and what are their relative strengths and weaknesses?

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

Populations

Inclusion
I. Humans
II. Adults (age >=18 years of age)
III. Patients with nonvalvular AF (including atrial flutter):
    A. Paroxysmal AF (recurrent episodes that self-terminate in less 
than 7 days)
    B. Persistent AF (recurrent episodes that last more than 7 days 
until stopped)
    C. Permanent AF (continuous)
    D. Patients with AF who experience acute coronary syndrome
IV. Subgroups of interest for KQ3 include (but are not limited to):
    A. Age
    B. Sex
    C. Race/ethnicity
    D. Presence of heart disease
    E. Type of AF
    F. Comorbid conditions (such as moderate to severe chronic kidney 
disease (eGFR <60), dementia)
    G. When in therapeutic range
    H. When non-adherent to medication
    I. Previous thromboembolic event
    J. Previous bleed
    K. Pregnant
Exclusion
    Patients who have known reversible causes of AF (including but not 
limited to postoperative, hyperthyroidism).
    All subjects are <18 years of age, or some subjects are under <18 
years of age but results are not broken down by age.

Intervention

Inclusion
    KQ 1: Clinical and imaging tools and associated risk factors for 
assessment/evaluation of thromboembolic risk:

I. Clinical tools include:
    A. CHADS2 score
    B. CHADS2-VASc score
    C. Framingham risk score
    D. ABC stroke risk score
II. Individual risk factors include:
    A. INR level
    B. Duration and frequency of AF
    C. Age
    D. Prior stroke
    E. Type of AF
    F. Cognitive impairment
    G. Falls risk
    H. Presence of heart disease
    I. Presence and severity of CKD
    J. DM
    K. Sex
    L. Race/ethnicity
    M. Cancer
    N. HIV
III. Imaging tools include:
    A. Transthoracic echo (TTE)
    B. Transesophageal echo (TEE)
    C. CT scans
    D. Cardiac MRIs

    KQ 2: Clinical tools and individual risk factors for assessment/
evaluation of intracranial hemorrhage bleeding risk:


[[Page 32370]]


I. Clinical tools include:
    A. HAS-BLED score
    B. HEMORR2HAGES score
    C. ATRIA score
    D. Bleeding Risk Index
    E. ABC Bleeding Risk score
II. Individual risk factors include:
    A. INR level
    B. Duration and frequency of AF
    C. Age
    D. Prior stroke
    E. Type of AF
    F. Cognitive impairment
    G. Falls risk
    H. Presence of heart disease
    I. Presence and severity of CKD
    J. DM
    K. Sex
    L. Race/ethnicity
    M. Cancer
    N. HIV

    KQ 3: Anticoagulation, antiplatelet, and procedural interventions:

I. Anticoagulation therapies:
    A. VKAs: Warfarin
    B. Newer anticoagulants (direct oral anticoagulants [DOACs])
    i. Direct thrombin Inh-DTI: Dabigatran
    ii. Factor Xa inhibitors:
    a. Rivaroxaban
    b. Apixaban
    c. Edoxaban
II. Antiplatelet therapies:
    A. Clopidogrel
    B. Aspirin
    C. Dipyridamole
    D. Combinations of antiplatelets
    i. Aspirin+dipyridamole
III. Procedures:
    A. Surgeries (e.g., left atrial appendage occlusion, resection/
removal)
    B. Minimally invasive (e.g., Atriclip, LARIAT)
    C. Transcatheter (WATCHMAN, AMPLATZER, PLAATO)
Exclusion
    None.

Comparator

Inclusion
    KQ 1: Other clinical or imaging tools listed for assessing 
thromboembolic risk.
    KQ 2: Other clinical tools listed for assessing bleeding risk.
    KQ 3: Other anticoagulation therapies, antiplatelet therapies, or 
procedural interventions for preventing thromboembolic events.
Exclusion
    For KQ 3, studies that did not include an active comparator.

Outcomes

Inclusion
I. Assessment of clinical and imaging tool efficacy for predicting 
thromboembolic risk and bleeding events (KQ1 and 2):
    A. Diagnostic accuracy efficacy
    B. Diagnostic thinking efficacy (defined as how using diagnostic 
technologies help or confirm the diagnosis of the referring provider)
    C. Therapeutic efficacy (defined as how the intended treatment plan 
compares with the actual treatment pursued before and after the 
diagnostic examination)
    D. Patient outcome efficacy (defined as the change in patient 
outcomes as a result of the diagnostic examination)

    Patient-centered outcomes for KQ3 (and for KQ1 [thromboembolic 
outcomes] and KQ2 [bleeding outcomes] under ``Patient outcome 
efficacy''):

II. Thromboembolic outcomes:
    A. Cerebrovascular infarction
    B. TIA
    C. Systemic embolism (excludes PE and DVT)
III. Bleeding outcomes:
    A. Hemorrhagic stroke
    B. Intracerebral hemorrhage
    C. Extracranial hemorrhage
    D. Major bleed (stratified by type and location)
    E. Minor bleed stratified by type and location)
IV. Other clinical outcomes:
    A. Mortality
    i. All-cause mortality
    ii. Cardiovascular mortality
    B. Myocardial infarction
    C. Infection
    D. Heart block
    E. Esophageal fistula
    F. Cardiac tamponade
    G. Dyspepsia
    H. Health-related quality of life
    I. Functional capacity
    J. Health services utilization (e.g., hospital admissions, 
outpatient office visits, ER visits, prescription drug use)
    K. Long-term adherence to therapy
    L. Cognitive function
Exclusion
    Study does not include any outcomes of interest.

Timing

Inclusion
    Timing of follow-up not limited.
Exclusion
    None.

Settings

Inclusion
    Inpatient and outpatient.
Exclusion
    None.

Study design

Inclusion
I. Original peer-reviewed data
II. N >=20 patients
III. RCTs, prospective and retrospective observational studies
Exclusion
    Not a clinical study (e.g., editorial, nonsystematic review, letter 
to the editor, case series, case reports).
    Abstract-only or poster publications; articles that have been 
retracted or withdrawn.
    Because studies with fewer than 20 subjects are often pilot studies 
or studies of lower quality, we will exclude them from our review.
    Systematic reviews, meta-analyses, or methods articles (used for 
background and component references only).

Language

Inclusion
I. English-language publications
II. Published on or after August 1, 2011
Exclusion
    Non-English-language publications.
    Relevant systematic reviews, meta-analyses, or methods articles 
(will be used for background only).

Sharon B. Arnold,
Deputy Director.
[FR Doc. 2017-14701 Filed 7-12-17; 8:45 am]
 BILLING CODE 4160-90-P

32368 Federal Register / Vol. 82, No. 133 / Thursday, July 13, 2017 / Notices EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS Number of Number of Minutes per Total burden Form name responses per respondents response hours respondent New RoPR Record entered manually through self-registration process ........ 16 1 55/60 14.67 New RoPR Record entered through ClinicalTrials.gov pathway ..................... 65 1 45/60 48.75 Review/update existing RoPR Record created through self-registration proc- ess ................................................................................................................ 33 1 20/60 11 Review/update existing RoPR Record created through ClinicalTrials.gov pathway ........................................................................................................ 132 1 15/60 33 Total .......................................................................................................... 246 ........................ ........................ 107.42 Exhibit 2 shows the estimated cost time to participate in the RoPR. The estimated at an average of $4,017.51 burden associated with the respondent’s total cost burden to respondents is annually. EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN Average Number of Total burden Total cost Form name hourly wage respondents hours burden rate † New RoPR Record entered manually through self-registration process ........ 16 14.67 $37.40 $548.66 New RoPR Record entered through ClinicalTrials.gov pathway ..................... 65 48.75 37.40 1,823.25 Review/update existing RoPR Record created through self-registration proc- ess ................................................................................................................ 33 11 37.40 411.40 Review/update existing RoPR Record created through ClinicalTrials.gov pathway ........................................................................................................ 132 33 37.40 1,234.20 Total .......................................................................................................... 246 107.42 37.40 4,017.51 † Based on the mean wages for Healthcare Practitioners and Technical Occupations, 29–0000. National Compensation Survey: Occupational wages in the United States May 2015, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ Available at: https://www.bls.gov/oes/current/ oes290000.htm. Request for Comments comments will become a matter of published and unpublished pertinent public record. scientific information will improve the In accordance with the Paperwork quality of this review. Reduction Act, comments on AHRQ’s Sharon B. Arnold, DATES: Submission Deadline on or information collection are requested Deputy Director. before August 14, 2017. with regard to any of the following: (a) [FR Doc. 2017–14703 Filed 7–12–17; 8:45 am] ADDRESSES: Whether the proposed collection of BILLING CODE 4160–90–P Email submissions: SEADS@epc- information is necessary for the proper src.org. performance of AHRQ health care Print submissions: DEPARTMENT OF HEALTH AND research and health care information Mailing Address: Portland VA HUMAN SERVICES dissemination functions, including Research Foundation, Scientific whether the information will have Agency for Healthcare Research and Resource Center, ATTN: Scientific practical utility; (b) the accuracy of Quality Information Packet Coordinator, P.O. AHRQ’s estimate of burden (including Box 69539, Portland, OR 97239. hours and costs) of the proposed Supplemental Evidence and Data Shipping Address (FedEx, UPS, etc.): collection(s) of information; (c) ways to Request on Stroke Prevention in Atrial Portland VA Research Foundation, enhance the quality, utility, and clarity Fibrillation Patients: A Systematic Scientific Resource Center, ATTN: of the information to be collected; and Review Update Scientific Information Packet (d) ways to minimize the burden of the Coordinator, 3710 SW U.S. Veterans AGENCY: Agency for Healthcare Research Hospital Road, Mail Code: R&D 71, collection of information upon the and Quality (AHRQ), HHS. Portland, OR 97239. respondents, including the use of ACTION: Request for supplemental automated collection techniques or FOR FURTHER INFORMATION CONTACT: evidence and data submissions. Ryan McKenna, Telephone: 503–220– other forms of information technology. SUMMARY: The Agency for Healthcare 8262 ext. 51723 or Email: SEADS@epc- Comments submitted in response to Research and Quality (AHRQ) is seeking src.org. this notice will be summarized and scientific information submissions from SUPPLEMENTARY INFORMATION: The sradovich on DSK3GMQ082PROD with NOTICES included in the Agency’s subsequent the public. Scientific information is Agency for Healthcare Research and request for OMB approval of the being solicited to inform our review of Quality has commissioned the proposed information collection. All Stroke Prevention in Atrial Fibrillation Evidence-based Practice Centers (EPC) Patients: A Systematic Review Update, Program to complete a review of the which is currently being conducted by evidence for Stroke Prevention in Atrial the AHRQ’s Evidence-based Practice Fibrillation Patients: A Systematic Centers (EPC) Program. Access to Review Update. AHRQ is conducting VerDate Sep<11>2014 17:41 Jul 12, 2017 Jkt 241001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\13JYN1.SGM 13JYN1

Federal Register / Vol. 82, No. 133 / Thursday, July 13, 2017 / Notices 32369 this systematic review pursuant to the review; or information on III. Patients with nonvalvular AF Section 902(a) of the Public Health indications not included in the review (including atrial flutter): Service Act, 42 U.S.C. 299a(a). cannot be used by the EPC Program. A. Paroxysmal AF (recurrent episodes The EPC Program is dedicated to This is a voluntary request for that self-terminate in less than 7 identifying as many studies as possible information, and all costs for complying days) that are relevant to the questions for with this request must be borne by the B. Persistent AF (recurrent episodes each of its reviews. In order to do so, we submitter. that last more than 7 days until are supplementing the usual manual The draft of this review will be posted stopped) and electronic database searches of the on AHRQ’s EPC Program Web site and C. Permanent AF (continuous) literature by requesting information available for public comment for a D. Patients with AF who experience from the public (e.g., details of studies period of 4 weeks. If you would like to acute coronary syndrome conducted). We are looking for studies be notified when the draft is posted, IV. Subgroups of interest for KQ3 that report on Stroke Prevention in please sign up for the email list at: include (but are not limited to): Atrial Fibrillation Patients: A Systematic https://www.effectivehealthcare. A. Age Review Update, including those that ahrq.gov/index.cfm/join-the-email- B. Sex describe adverse events. The entire list1/. C. Race/ethnicity research protocol, including the key The systematic review will answer the D. Presence of heart disease questions, is also available online at: following questions. This information is E. Type of AF https://effectivehealthcare.ahrq.gov/ provided as background. AHRQ is not F. Comorbid conditions (such as index.cfm/search-for-guides-reviews- requesting that the public provide moderate to severe chronic kidney and-reports/?pageaction= answers to these questions. disease (eGFR <60), dementia) displayproduct&productid=2481. G. When in therapeutic range This is to notify the public that the The Key Questions H. When non-adherent to medication EPC Program would find the following I. In patients with nonvalvular atrial I. Previous thromboembolic event information on Stroke Prevention in fibrillation, what are the J. Previous bleed Atrial Fibrillation Patients: A Systematic comparative diagnostic accuracy K. Pregnant Review Update helpful: and impact on clinical decision- D A list of completed studies that Exclusion making (diagnostic thinking, your organization has sponsored for this therapeutic and patient outcome Patients who have known reversible indication. In the list, please indicate efficacy) of available clinical and causes of AF (including but not limited whether results are available on imaging tools and associated risk to postoperative, hyperthyroidism). ClinicalTrials.gov along with the factors for predicting All subjects are <18 years of age, or ClinicalTrials.gov trial number. thromboembolic risk? some subjects are under <18 years of age D For completed studies that do not II. In patients with nonvalvular atrial but results are not broken down by age. have results on ClinicalTrials.gov, fibrillation, what are the please provide a summary, including Intervention comparative diagnostic accuracy the following elements: Study number, and impact on clinical decision- Inclusion study period, design, methodology, making (diagnostic thinking, indication and diagnosis, proper use KQ 1: Clinical and imaging tools and therapeutic, and patient outcome associated risk factors for assessment/ instructions, inclusion and exclusion efficacy) of clinical tools and criteria, primary and secondary evaluation of thromboembolic risk: associated risk factors for predicting outcomes, baseline characteristics, I. Clinical tools include: bleeding events? number of patients screened/eligible/ III. What are the comparative safety and A. CHADS2 score enrolled/lost to follow-up/withdrawn/ effectiveness of specific B. CHADS2–VASc score analyzed, effectiveness/efficacy, and anticoagulation therapies, C. Framingham risk score safety results. antiplatelet therapies, and D. ABC stroke risk score D A list of ongoing studies that your procedural interventions for II. Individual risk factors include: organization has sponsored for this A. INR level preventing thromboembolic events: indication. In the list, please provide the A. In patients with nonvalvular atrial B. Duration and frequency of AF ClinicalTrials.gov trial number or, if the fibrillation? C. Age trial is not registered, the protocol for B. In specific subpopulations of D. Prior stroke the study including a study number, the patients with nonvalvular atrial E. Type of AF study period, design, methodology, fibrillation? F. Cognitive impairment indication and diagnosis, proper use G. Falls risk instructions, inclusion and exclusion Contextual Question H. Presence of heart disease criteria, and primary and secondary What are currently available shared I. Presence and severity of CKD outcomes. decision-making tools for patient and J. DM D Description of whether the above provider use for stroke prophylaxis in K. Sex studies constitute ALL Phase II and atrial fibrillation, and what are their L. Race/ethnicity above clinical trials sponsored by your relative strengths and weaknesses? M. Cancer organization for this indication and an N. HIV PICOTS (Populations, Interventions, III. Imaging tools include: sradovich on DSK3GMQ082PROD with NOTICES index outlining the relevant information in each submitted file. Comparators, Outcomes, Timing, A. Transthoracic echo (TTE) Your contribution will be very Settings) B. Transesophageal echo (TEE) beneficial to the EPC Program. Materials Populations C. CT scans submitted must be publicly available or D. Cardiac MRIs able to be made public. Materials that Inclusion KQ 2: Clinical tools and individual are considered confidential; marketing I. Humans risk factors for assessment/evaluation of materials; study types not included in II. Adults (age ≥18 years of age) intracranial hemorrhage bleeding risk: VerDate Sep<11>2014 18:43 Jul 12, 2017 Jkt 241001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\13JYN1.SGM 13JYN1

32370 Federal Register / Vol. 82, No. 133 / Thursday, July 13, 2017 / Notices I. Clinical tools include: thromboembolic risk and bleeding Study design A. HAS–BLED score events (KQ1 and 2): B. HEMORR2HAGES score A. Diagnostic accuracy efficacy Inclusion C. ATRIA score B. Diagnostic thinking efficacy I. Original peer-reviewed data D. Bleeding Risk Index (defined as how using diagnostic II. N ≥20 patients E. ABC Bleeding Risk score technologies help or confirm the III. RCTs, prospective and retrospective II. Individual risk factors include: diagnosis of the referring provider) observational studies A. INR level C. Therapeutic efficacy (defined as B. Duration and frequency of AF Exclusion how the intended treatment plan C. Age compares with the actual treatment Not a clinical study (e.g., editorial, D. Prior stroke nonsystematic review, letter to the E. Type of AF pursued before and after the diagnostic examination) editor, case series, case reports). F. Cognitive impairment Abstract-only or poster publications; G. Falls risk D. Patient outcome efficacy (defined as the change in patient outcomes articles that have been retracted or H. Presence of heart disease as a result of the diagnostic withdrawn. I. Presence and severity of CKD J. DM examination) Because studies with fewer than 20 K. Sex subjects are often pilot studies or Patient-centered outcomes for KQ3 studies of lower quality, we will L. Race/ethnicity (and for KQ1 [thromboembolic M. Cancer exclude them from our review. outcomes] and KQ2 [bleeding outcomes] Systematic reviews, meta-analyses, or N. HIV under ‘‘Patient outcome efficacy’’): KQ 3: Anticoagulation, antiplatelet, methods articles (used for background II. Thromboembolic outcomes: and component references only). and procedural interventions: A. Cerebrovascular infarction I. Anticoagulation therapies: B. TIA Language A. VKAs: Warfarin C. Systemic embolism (excludes PE B. Newer anticoagulants (direct oral Inclusion and DVT) anticoagulants [DOACs]) III. Bleeding outcomes: I. English-language publications i. Direct thrombin Inh-DTI: Dabigatran A. Hemorrhagic stroke II. Published on or after August 1, 2011 ii. Factor Xa inhibitors: B. Intracerebral hemorrhage a. Rivaroxaban Exclusion C. Extracranial hemorrhage b. Apixaban D. Major bleed (stratified by type and Non-English-language publications. c. Edoxaban location) Relevant systematic reviews, meta- II. Antiplatelet therapies: E. Minor bleed stratified by type and analyses, or methods articles (will be A. Clopidogrel location) used for background only). B. Aspirin IV. Other clinical outcomes: C. Dipyridamole Sharon B. Arnold, A. Mortality D. Combinations of antiplatelets i. All-cause mortality Deputy Director. i. Aspirin+dipyridamole ii. Cardiovascular mortality [FR Doc. 2017–14701 Filed 7–12–17; 8:45 am] III. Procedures: B. Myocardial infarction BILLING CODE 4160–90–P A. Surgeries (e.g., left atrial C. Infection appendage occlusion, resection/ D. Heart block removal) E. Esophageal fistula DEPARTMENT OF HEALTH AND B. Minimally invasive (e.g., Atriclip, F. Cardiac tamponade HUMAN SERVICES LARIAT) G. Dyspepsia C. Transcatheter (WATCHMAN, H. Health-related quality of life Agency for Healthcare Research and AMPLATZER, PLAATO) I. Functional capacity Quality Exclusion J. Health services utilization (e.g., hospital admissions, outpatient Patient Safety Organizations: None. office visits, ER visits, prescription Voluntary Relinquishment From the drug use) Catholic Health Initiatives Patient Comparator K. Long-term adherence to therapy Safety Organization, LLC Inclusion L. Cognitive function AGENCY: Agency for Healthcare Research KQ 1: Other clinical or imaging tools Exclusion and Quality (AHRQ), Department of listed for assessing thromboembolic Health and Human Services (HHS). risk. Study does not include any outcomes of interest. ACTION: Notice of delisting. KQ 2: Other clinical tools listed for assessing bleeding risk. Timing SUMMARY: The Patient Safety Rule KQ 3: Other anticoagulation therapies, authorizes AHRQ, on behalf of the antiplatelet therapies, or procedural Inclusion Secretary of HHS, to list as a PSO an interventions for preventing Timing of follow-up not limited. entity that attests that it meets the thromboembolic events. statutory and regulatory requirements Exclusion Exclusion for listing. A PSO can be ‘‘delisted’’ by None. the Secretary if it is found to no longer sradovich on DSK3GMQ082PROD with NOTICES For KQ 3, studies that did not include meet the requirements of the Patient an active comparator. Settings Safety Act and Patient Safety Rule, Outcomes Inclusion when a PSO chooses to voluntarily Inpatient and outpatient. relinquish its status as a PSO for any Inclusion reason, or when a PSO’s listing expires. I. Assessment of clinical and imaging Exclusion AHRQ has accepted a notification of tool efficacy for predicting None. voluntary relinquishment from the VerDate Sep<11>2014 17:41 Jul 12, 2017 Jkt 241001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\13JYN1.SGM 13JYN1


Document Created: 2017-07-13 01:00:33
Document Modified: 2017-07-13 01:00:33
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionRequest for supplemental evidence and data submissions.
DatesSubmission Deadline on or before August 14, 2017.
ContactRyan McKenna, Telephone: 503-220-8262 ext. 51723 or Email: [email protected]
FR Citation82 FR 32368 
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