Supplemental Evidence and Data Request on Stroke Prevention in Atrial Fibrillation Patients: A Systematic Review Update, 32368-32370 [2017-14701]

Download as PDF 32368 Federal Register / Vol. 82, No. 133 / Thursday, July 13, 2017 / Notices EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS New RoPR Record entered manually through self-registration process ........ New RoPR Record entered through ClinicalTrials.gov pathway ..................... Review/update existing RoPR Record created through self-registration process ................................................................................................................ Review/update existing RoPR Record created through ClinicalTrials.gov pathway ........................................................................................................ Total .......................................................................................................... Exhibit 2 shows the estimated cost burden associated with the respondent’s Number of responses per respondent Number of respondents Form name Minutes per response Total burden hours 16 65 1 1 55/60 45/60 14.67 48.75 33 1 20/60 11 132 1 15/60 33 246 ........................ ........................ 107.42 time to participate in the RoPR. The total cost burden to respondents is estimated at an average of $4,017.51 annually. EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN Number of respondents Form name New RoPR Record entered manually through self-registration process ........ New RoPR Record entered through ClinicalTrials.gov pathway ..................... Review/update existing RoPR Record created through self-registration process ................................................................................................................ Review/update existing RoPR Record created through ClinicalTrials.gov pathway ........................................................................................................ Total .......................................................................................................... Total burden hours Average hourly wage rate † Total cost burden 16 65 14.67 48.75 $37.40 37.40 $548.66 1,823.25 33 11 37.40 411.40 132 33 37.40 1,234.20 246 107.42 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. sradovich on DSK3GMQ082PROD with NOTICES Request for Comments In accordance with the Paperwork Reduction Act, comments on AHRQ’s information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ’s estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and included in the Agency’s subsequent request for OMB approval of the proposed information collection. All VerDate Sep<11>2014 17:41 Jul 12, 2017 Jkt 241001 comments will become a matter of public record. Sharon B. Arnold, Deputy Director. [FR Doc. 2017–14703 Filed 7–12–17; 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 Stroke Prevention in Atrial Fibrillation Patients: 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 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 SUMMARY: PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 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: 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 Stroke Prevention in Atrial Fibrillation Patients: A Systematic Review Update. AHRQ is conducting E:\FR\FM\13JYN1.SGM 13JYN1 sradovich on DSK3GMQ082PROD with NOTICES Federal Register / Vol. 82, No. 133 / Thursday, July 13, 2017 / Notices 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-reviewsand-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: 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 VerDate Sep<11>2014 18:43 Jul 12, 2017 Jkt 241001 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-emaillist1/. 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 decisionmaking (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 decisionmaking (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) PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 32369 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: E:\FR\FM\13JYN1.SGM 13JYN1 32370 Federal Register / Vol. 82, No. 133 / Thursday, July 13, 2017 / Notices 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 sradovich on DSK3GMQ082PROD with NOTICES 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 VerDate Sep<11>2014 17:41 Jul 12, 2017 Jkt 241001 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 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, metaanalyses, 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety Organizations: Voluntary Relinquishment From the Catholic Health Initiatives Patient Safety Organization, LLC Exclusion Study does not include any outcomes of interest. Agency for Healthcare Research and Quality (AHRQ), Department of Health and Human Services (HHS). ACTION: Notice of delisting. Timing SUMMARY: Inclusion Timing of follow-up not limited. Exclusion None. Settings Inclusion Inpatient and outpatient. Exclusion None. PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 AGENCY: The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ‘‘delisted’’ by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO’s listing expires. AHRQ has accepted a notification of voluntary relinquishment from the E:\FR\FM\13JYN1.SGM 13JYN1

Agencies

[Federal Register Volume 82, Number 133 (Thursday, July 13, 2017)]
[Notices]
[Pages 32368-32370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14701]


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

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