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. Author manuscript; available in PMC: 2019 Dec 1.
Published in final edited form as: Thromb Haemost. 2018 Oct 30;118(12):2171–2187. doi: 10.1055/s-0038-1675400

Appendix Table 2.

Inclusion and Exclusion Criteria

PICOTS
Element
Inclusion Criteria Exclusion Criteria
Populations
  • Adults (≥18 years of age)

  • Patients with nonvalvular AF (including atrial flutter):
    • Paroxysmal AF (recurrent episodes that self-terminate in less than 7 days)
    • Persistent AF (recurrent episodes that last more than 7 days until stopped)
    • Permanent AF (continuous)
    • Patients with AF who experience acute coronary syndrome
  • Subgroups of interest for KQ 3 include (but are not limited to):
    • Age
    • Sex
    • Race/ethnicity
    • Presence of heart disease
    • Type of AF
    • Comorbid conditions (such as moderate to severe chronic kidney disease (eGFR<60), dementia)
    • When in therapeutic range
    • When non-adherent to medication
    • Previous thromboembolic event
    • Previous bleed
    • Pregnant
  • 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

Interventions KQ 1: Clinical and imaging tools and associated risk factors for assessment/evaluation of thromboembolic risk:
  • Clinical tools include:
    • CHADS2 score
    • CHADS2-VASc score
    • Framingham risk score
    • ABC stroke risk score
  • Individual risk factors include:
    • INR level
    • Duration and frequency of AF
    • Age
    • Prior stroke
    • Type of AF
    • Cognitive impairment
    • Falls risk
    • Presence of heart disease
    • Presence and severity of CKD
    • DM
    • Sex
    • Race/ethnicity
    • Cancer
    • HIV
  • Imaging tools include:
    • Transthoracic echo (TTE)
    • Transesophageal echo (TEE)
    • CT scans
    • Cardiac MRIs

KQ 2: Clinical tools and individual risk factors for assessment/evaluation of intracranial hemorrhage bleeding risk:
  • Clinical tools include:
    • HAS-BLED score
    • HEMORR2HAGES score
    • ATRIA score
    • Bleeding Risk Index
    • ABC Bleeding Risk score
  • Individual risk factors include:
    • INR level
    • Duration and frequency of AF
    • Age
    • Prior stroke
    • Type of AF
    • Cognitive impairment
    • Falls risk
    • Presence of heart disease
    • Presence and severity of CKD
    • DM
    • Sex
    • Race/ethnicity
    • Cancer
    • HIV

KQ 3: Anticoagulation, antiplatelet, and procedural interventions:
  • Anticoagulation therapies:
    • VKAs: Warfarin
    • Newer anticoagulants (direct oral anticoagulants [DOACs])
      • Direct thrombin Inh-DTI: Dabigatran
      • Factor Xa inhibitors:
        • Rivaroxaban
        • Apixaban
        • Edoxaban
  • Antiplatelet therapies:
    • Clopidogrel
    • Aspirin
    • Dipyridamole
    • Combinations of antiplatelets
      • Aspirin+dipyridamole
  • Procedures:
    • Surgeries (e.g., left atrial appendage occlusion, resection/removal)
    • Minimally invasive (e.g., Atriclip, LARIAT)
    • Transcatheter (WATCHMAN™, AMPLATZER™, PLAATO)
None
Comparators
  • 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

For KQ 3, studies that did not include an active comparator
Outcomes
  • Assessment of clinical and imaging tool efficacy for predicting thromboembolic risk and bleeding events (KQs 1 and 2):
    • Diagnostic accuracy efficacy
    • Diagnostic thinking efficacy (defined as how using diagnostic technologies help or confirm the diagnosis of the referring provider)
    • Therapeutic efficacy (defined as how the intended treatment plan compares with the actual treatment pursued before and after the diagnostic examination)
    • Patient outcome efficacy (defined as the change in patient outcomes as a result of the diagnostic examination)

Patient-centered outcomes for KQ 3 (and for KQ 1 [thromboembolic outcomes] and KQ 2 [bleeding outcomes] under “Patient outcome efficacy”):
  • Thromboembolic outcomes:
    • Cerebrovascular infarction
    • TIA
    • Systemic embolism (excludes PE and DVT)
  • Bleeding outcomes:
    • Hemorrhagic stroke
    • Intracranial hemorrhage (intracerebral hemorrhage, subdural hematoma)
    • Major and minor bleed (stratified by type and location)a
  • Other clinical outcomes:
    • Mortality
      • All-cause mortality
      • Cardiovascular mortality
    • Myocardial infarction
    • Infection
    • Heart block
    • Esophageal fistula
    • Cardiac tamponade
    • Dyspepsia
    • Health-related quality of life
    • Functional capacity
    • Health services utilization (e.g., hospital admissions, outpatient office visits, ER visits, prescription drug use)
    • Long-term adherence to therapy
    • Cognitive function
Study does not include any outcomes of interest
Timing
  • Timing of followup not limited

None
Setting
  • Inpatient and outpatient

Studies which were conducted exclusively in Asia, Africa, or the Middle Eastb
Study design
  • Original peer-reviewed data

  • N ≥20 patients

  • RCTs, prospective and retrospective observational studies

  • 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,110,111 we excluded them from our review

  • Systematic reviews, meta-analyses, or methods articles (used for background and component references only)

  • Observational studies that are only relevant to KQ 3 (treatment), have fewer than 1000 patients, and only target pharmacological interventionsc

Publications
  • English-language publications

  • Published on or after January 1, 2000

  • Non–English-language publicationsd

  • Relevant systematic reviews, meta-analyses, or methods articles (will be used for background only)