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Al-Khatib SM, Lapointe NA, Chatterjee R, et al. Treatment of Atrial Fibrillation [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Jun. (Comparative Effectiveness Reviews, No. 119.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

Cover of Treatment of Atrial Fibrillation

Treatment of Atrial Fibrillation [Internet].

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Appendix BData Abstraction Elements

Study Characteristics

  • Study Identifiers
    • Study Name or Acronym
    • Last name of first author
    • Publication Year
  • Additional Articles Used in This Abstraction
  • Study Objectives
  • Study Dates
    • Enrollment Start (Mon and YYYY)
    • Enrollment End (Mon and YYYY)
    • Follow-up End (Mon and YYYY)
  • Study Sites
    • Single Center, Multicenter, Unclear/Not reported, Other (specify)
    • Number of sites
  • Geographic Location (Select all that apply)
    • US, Canada, UK, Europe, S. America, C. America, Asia, Africa, Australia/NZ, Unclear/Not reported, Other (specify)
  • Study Design
    • Prospective RCT
    • Prospective cohort
    • Retrospective cohort
    • Case-control
    • Cross-sectional
    • Other (specify)
  • Funding Source (Select all that apply)
    • Government, Industry, Non-govt/Non-industry, Unclear/Not reported, Other (specify)
  • Setting (Select all that apply)
    • In-patient, Out-patient, Emergency Room, Unclear/Not reported, Other (specify)
  • Enrollment Approach (Select all that apply)
    • Consecutive patients, Convenience sample, Unclear/Not reported, Other (specify)
  • Study Inclusion and Exclusion Criteria
    • Copy/paste inclusion and exclusion criteria as reported
    • Is the study entirely composed of patients with any of the following characteristics/ conditions?
      • Paroxysmal AF
      • Persistent AF
      • Permanent AF
      • Heart failure
      • Coronary artery disease
      • Kidney disease
      • Hypertrophic cardiomyopathy
      • Thyroid disease
      • Pulmonary disease
      • Previously failed a rate- or rhythm-control pharmacological therapy strategy
      • Enlarged left atrium
      • High risk for stroke and bleeding events (e.g., patients with diabetes, heart failure, and hypertension)
      • Women
      • None of the above
  • Study Enrollment/Study Completion
    • N Assessed for eligibility
    • N eligible
    • N enrolled/included
    • N completed follow-up (most distal timepoint of the primary outcome)
    • N analyzed
  • Key Question Applicability (select all that apply)
  • Comments

Baseline Characteristics. Record the following elements for Total Population, Arm 1, Arm 2, Arm 3, and Arm 4 (as applicable)

  • Number of Patients, Age, Ethnicity, and Race
    • Number of Patients
      • Total
      • Female
      • Male
    • Percentage
      • Female
      • Male
    • Age
      • Mean
      • Standard Deviation
      • Standard Error
      • Median
      • IQR
      • Min
      • Max
      • NR
    • Ethnicity
      • Hispanic or Latino
      • Not Hispanic or Latino
      • NR
    • Race
      • Black/African American
      • American Indian or Alaska Native
      • Asian
      • Native Hawaiian or other Pacific Islander
      • White
      • Multiracial
      • Other (specify)
      • NR
  • Co-morbidities and Previous Treatment Failures
    • Diabetes
      • N
      • %
    • Heart failure, All types (define)
      • N
      • %
    • Heart failure, Systolic (define)
      • N
      • %
    • Heart failure, Diastolic (define)
      • N
      • %
    • Hypertension
      • N
      • %
    • Kidney disease (define)
      • N
      • %
    • Hypertrophic cardiomyopathy (define)
      • N
      • %
    • Thyroid disease (define)
      • N
      • %
    • Pulmonary disease (define)
      • N
      • %
    • Coronary artery disease
      • N
      • %
    • Enlarged left atrium (define)
      • N
      • %
    • LVEF, Mean or median
      • Mean
      • Median
      • SD
      • SE
      • IQR
    • LVEF, Number of patients (<35% or other [define])
      • N
      • %
    • Previously failed rate-control pharmacological therapy (define)
      • N
      • %
    • Previously failed rhythm-control pharmacological therapy (define)
      • N
      • %
    • Duration of AF (include units)
      • mean
      • Median
      • SD
      • SE
      • IQR
    • Permanent AF
      • N
      • %
    • Paroxysmal AF
      • N
      • %
    • Persistent AF
      • N
      • %
  • Comments

Intervention Characteristics. Record the following elements for Arm 1, Arm 2, Arm 3, and Arm 4 (as applicable)

  • Intervention Characteristics
    • Intervention Components (check all that apply)
      • Placebo or control
      • Pharmacological agents for rate control
      • Procedures for rate control
      • Pharmacological agents for rhythm control
      • Procedures for rhythm control
    • Placebo/Control Details
      • Placebo
      • Usual care control/optimal medical therapy
      • Other (specify)
    • Rate-control Pharmacological Agent Details
      • Beta-blockers
        • Acebutolol
        • Atenolol
        • Bisoprolol
        • Carvedilol
        • Esmolol
        • Metoprolol
        • Nadalol
        • Nebivolol
        • Timolol
        • Specific medication not reported
      • Calcium channel blockers
        • Diltiazem
        • Verapamil
        • Specific medication not reported
        • Other
          • Amiodarone
          • Digoxin
          • Dronedarone
          • Specific medication not reported
    • Rate-control Procedure Details
      • AVN ablation and permanent pacemaker implantation
    • Rate-control Target
      • Strict (define)
      • Lenient (define)
      • Other (define)
      • NA
    • Rhythm-control Pharmacological Agent Details
      • Amiodarone
      • Beta-blockers
        • Acebutolol
        • Atenolol
        • Carvedilol
        • Esmolol
        • Metoprolol
        • Nadalol
        • Nebivolol
        • Timolol
        • Specific medication not reported
      • Calcium channel blockers
        • Diltiazem
        • Verapamil
        • Specific medication not reported
      • Disopyramide
      • Dofetilide
      • Dronedarone
      • Flecainide
      • Ibutilide
      • Propafenone
      • Sotalol
    • Rhythm-control Procedure Details
      • Electrical cardioversion
      • Pulmonary vein ablation – open surgical
      • Pulmonary vein ablation – minimally invasive
      • Pulmonary vein ablation – transcatheter
      • Surgical Maze
      • Cardiac resynchronization
  • Intervention Descriptors
    • Describe the intervention received by patients in Arm 1, Arm 2, Arm 3, and Arm 4 (as applicable)
  • Duration of Follow-up - Record the following elements for Arm 1, Arm 2, Arm 3, and Arm 4 (as applicable)
    • Mean follow-up
    • Mean Variability (SD, SE, IQR)
    • Median follow-up
    • Median Variability (SD, SE, IQR)
  • Comments

Outcomes

  • Select the outcome reported on this form
    • Restoration of sinus rhythm (conversion)
    • Maintenance of sinus rhythm
    • Recurrence of AF (specify time period)
    • Development of cardiomyopathy
    • All-cause mortality
    • Cardiac mortality
    • Myocardial infarction
    • CV hospitalizations
    • AF Hospitalizations
    • Heart failure symptoms
    • Control of AF symptoms (e.g., palpitations, exercise capacity)
    • Quality of life/ Functional status
    • Stroke
    • Other embolic events, excluding stroke (specify)
    • Mixed embolic events including stroke
    • Bleeding events (including hemorrhagic stroke)
    • Control of ventricular rate
    • Composite outcome
  • Define/specify the following for the outcome, if applicable
    • Quality of life or functional status measure/scale
    • Stroke
    • Other embolic event
    • Control of ventricular rate
    • Components of composite outcomes
  • Record additional details to describe outcome measure, as needed
  • Timepoints to be abstracted (check all that apply)
    • Close to 1 month
    • Close to 3 months
    • Close to 6 months
    • Close to 1 yr
    • Most distal timepoint after one year
    • Untimed measure (e.g. time to event)
  • For each timepoint, record the following elements as applicable
    • Group – Arm 1, Arm 2, Arm 3, Arm 4
    • N Analyzed (enter UNK if unknown)
    • Unadjusted Result
      • Mean
      • Median
      • Mean within group change
      • Mean between group change
      • Number of patients with outcome
      • % of patients with outcome
      • Events/denominator
      • Odds ratio (OR)
      • Hazard ratio (HR)
      • Relative risk (RR)
      • Other (specify)
    • Unadjusted Variability
      • Standard Error (SE)
      • Standard Deviation (SD)
      • IQR
      • 95% CI
      • Other % CI (specify)
      • Other (specify)
    • Unadjusted p-value between groups
    • Unadjusted Reference group (for comparison between groups)
    • Adjusted Result
      • Mean
      • Median
      • Mean within group change
      • Mean between group change
      • Number of patients with outcome
      • % of patients with outcome
      • Events/denominator
      • Odds ratio
      • Hazard ratio
      • Relative risk
      • Other (specify)
    • Adjusted Variability
      • Standard Error (SE)
      • Standard Deviation (SD)
      • IQR
      • 95% CI
      • Other % CI (specify)
      • Other (specify)
    • Adjusted p-value between groups
    • Adjusted Reference group (for comparison between groups)
    • Indicate the adjustments applied
  • Subgroup analyses reported for this outcome?
    • Yes/No
      • If Yes, describe the subgroup analyses and summarize results
  • Comments

Adverse Events

  • Are adverse events reported? (Yes/No)
  • Record the Number of patients, % of patients, and exact p-value the Total Population, Arm 1, Arm 2, Arm 3, and Arm 4 (as applicable) for the following:
    • Hypotension
    • Hypothyroidism
    • Hyperthyroidism
    • Bradyarrhythmias
    • Tachyarrhythmias
    • Proarrhythmias
    • Allergic Reactions
    • Hepatotoxicity
    • Neurotoxicity
    • Pulmonary Toxicity
    • Ophthalmologic Toxicity
    • Dermatologic Toxicity
    • Pulmonary Vein Stenosis
    • Left Atrial Esophageal Fistula
    • Phrenic Nerve Palsy
    • Other Adverse Drug Reaction (specify)
    • Other Procedural Complication (specify)
  • Subgroup analyses reported for adverse events?
    • Yes/No
      • If yes, describe the subgroup analyses and summarize results
  • Comments

Quality Assessment

  • Study Type
    • RCT
    • Cohort
    • Case-Control
    • Cross-sectional
  • If RCT:
    • Selection Bias
      • Was the allocation sequence generated adequately (e.g., random number table, computer-generated randomization)? (Yes/No/Unclear)
      • Was the allocation of treatment adequately concealed (e.g., pharmacy-controlled randomization or use of sequentially numbered sealed envelopes)? (Yes/No/Unclear)
      • Were participants analyzed within the groups they were originally assigned to? (Yes/No/Unclear)
      • Does the design or analysis control account for important confounding and modifying variables through matching, stratification, multivariable analysis, or other approaches? (Yes/No/Unclear)
    • Performance Bias
      • Did researchers rule out any impact from a concurrent intervention or an unintended exposure that might bias results? (Yes/No/Unclear)
      • Did the study maintain fidelity to the intervention protocol? (Yes/No/Unclear)
    • Attrition Bias
      • If attrition (overall or differential nonresponse, dropout, loss to follow-up, or exclusion of participants) was a concern, were missing data handled appropriately (e.g., intention-to-treat analysis and imputation)? (Yes/No/Unclear)
    • Detection Bias
      • In prospective studies, was the length of follow-up different between the groups, or in case-control studies, was the time period between the intervention/exposure and outcome different for cases and controls? (Yes/No/Unclear)
      • Were the outcome assessors blinded to the intervention or exposure status of participants? (Yes/No/Unclear)
      • Were interventions/exposures assessed/defined using valid and reliable measures, implemented consistently across all study participants? (Yes/No/Unclear)
      • Were outcomes assessed/defined using valid and reliable measures, implemented consistently across all study participants? (Yes/No/Unclear)
    • Reporting Bias
      • Were the potential outcomes prespecified by the researchers? Are all prespecified outcomes reported? (Yes/No/Unclear)
  • If Cohort:
    • Selection Bias
      • Were participants analyzed within the groups they were originally assigned to? (Yes/No/Unclear)
      • Did the study apply inclusion/exclusion criteria uniformly to all comparison groups? (Yes/No/Unclear)
      • Did the strategy for recruiting participants into the study differ across study groups? (Yes/No/Unclear)
      • Does the design or analysis control account for important confounding and modifying variables through matching, stratification, multivariable analysis, or other approaches? (Yes/No/Unclear)
    • Performance Bias
      • Did researchers rule out any impact from a concurrent intervention or an unintended exposure that might bias results? (Yes/No/Unclear)
      • Did the study maintain fidelity to the intervention protocol? (Yes/No/Unclear)
    • Attrition Bias
      • If attrition (overall or differential nonresponse, dropout, loss to follow-up, or exclusion of participants) was a concern, were missing data handled appropriately (e.g., intention-to-treat analysis and imputation)? (Yes/No/Unclear)
    • Detection Bias
      • In prospective studies, was the length of follow-up different between the groups, or in case-control studies, was the time period between the intervention/exposure and outcome different for cases and controls? (Yes/No/Unclear)
      • Were the outcome assessors blinded to the intervention or exposure status of participants? (Yes/No/Unclear)
      • Were interventions/exposures assessed/defined using valid and reliable measures, implemented consistently across all study participants? (Yes/No/Unclear)
      • Were outcomes assessed/defined using valid and reliable measures, implemented consistently across all study participants? (Yes/No/Unclear)
      • Were confounding variables assessed using valid and reliable measures, implemented consistently across all study participants? (Yes/No/Unclear)
    • Reporting Bias
      • Were the potential outcomes prespecified by the researchers? Are all prespecified outcomes reported? (Yes/No/Unclear)
  • If Case-Control:
    • Selection Bias
      • Were cases and controls selected appropriately (e.g., appropriate diagnostic criteria or definitions, equal application of exclusion criteria to case and controls, sampling not influenced by exposure status) (Yes/No/Unclear)
      • Does the design or analysis control account for important confounding and modifying variables through matching, stratification, multivariable analysis, or other approaches? (Yes/No/Unclear)
    • Performance Bias
      • Did researchers rule out any impact from a concurrent intervention or an unintended exposure that might bias results? (Yes/No/Unclear)
      • Did the study maintain fidelity to the intervention protocol? (Yes/No/Unclear)
    • Attrition Bias
      • If attrition (overall or differential nonresponse, dropout, loss to follow-up, or exclusion of participants) was a concern, were missing data handled appropriately (e.g., intention-to-treat analysis and imputation)? (Yes/No/Unclear)
    • Detection Bias
      • In prospective studies, was the length of follow-up different between the groups, or in case-control studies, was the time period between the intervention/exposure and outcome different for cases and controls? (Yes/No/Unclear)
      • Were the outcome assessors blinded to the intervention or exposure status of participants? (Yes/No/Unclear)
      • Were interventions/exposures assessed/defined using valid and reliable measures, implemented consistently across all study participants? (Yes/No/Unclear)
      • Were outcomes assessed/defined using valid and reliable measures, implemented consistently across all study participants? (Yes/No/Unclear)
      • Were confounding variables assessed using valid and reliable measures, implemented consistently across all study participants? (Yes/No/Unclear)
    • Reporting Bias
      • Were the potential outcomes prespecified by the researchers? Are all prespecified outcomes reported? (Yes/No/Unclear)
  • If Cross-sectional:
    • Selection Bias
      • Did the study apply inclusion/exclusion criteria uniformly to all comparison groups? (Yes/No/Unclear)
      • Does the design or analysis control account for important confounding and modifying variables through matching, stratification, multivariable analysis, or other approaches? (Yes/No/Unclear)
    • Performance Bias
      • Did researchers rule out any impact from a concurrent intervention or an unintended exposure that might bias results? (Yes/No/Unclear)
    • Attrition Bias
      • If attrition (overall or differential nonresponse, dropout, loss to follow-up, or exclusion of participants) was a concern, were missing data handled appropriately (e.g., intention-to-treat analysis and imputation)? (Yes/No/Unclear)
    • Detection Bias
      • Were the outcome assessors blinded to the intervention or exposure status of participants? (Yes/No/Unclear)
      • Were interventions/exposures assessed/defined using valid and reliable measures, implemented consistently across all study participants? (Yes/No/Unclear)
      • Were outcomes assessed/defined using valid and reliable measures, implemented consistently across all study participants? (Yes/No/Unclear)
      • Were confounding variables assessed using valid and reliable measures, implemented consistently across all study participants? (Yes/No/Unclear)
    • Reporting Bias
      • Were the potential outcomes prespecified by the researchers? Are all prespecified outcomes reported? (Yes/No/Unclear)
  • Other Bias
    • If applicable, describe any other concerns that may impact risk of bias.
  • Overall Study Rating (Good/Fair/Poor)
    • Good (low risk of bias). These studies have the least bias, and the results are considered valid. These studies adhere to the commonly held concepts of high quality, including the following: a clear description of the population, setting, approaches, and comparison groups; appropriate measurement of outcomes; appropriate statistical and analytical methods and reporting; no reporting errors; a low dropout rate; and clear reporting of dropouts.
    • Fair. These studies are susceptible to some bias, but not enough to invalidate the results. They do not meet all the criteria required for a rating of good quality because they have some deficiencies, but no flaw is likely to cause major bias. The study may be missing information, making it difficult to assess limitations and potential problems.
    • Poor (high risk of bias). These studies have significant flaws that may have invalidated the results. They have serious errors in design, analysis, or reporting; large amounts of missing information; or discrepancies in reporting.
    • If the study is rated as “Fair” or “Poor,” provide rationale.

Applicability. Use the PICOS format to identify specific issues, if any, that may limit the applicability of the study to this review.

  • Population (P)
    • Narrow eligibility criteria and exclusion of those with comorbidities
    • Large differences between demographics of study population and community patients
    • Narrow or unrepresentative severity, stage of illness, or comorbidities
    • Run-in period with high exclusion rate for nonadherence or side effects
    • Event rates much higher or lower than observed in population-based studies
  • Intervention (I)
    • Doses or schedules not reflected in current practice
    • Monitoring practices or visit frequency not used in typical practice
    • Older versions of an intervention no longer in common use
    • Cointerventions that are likely to modify effectiveness of therapy
    • Highly selected intervention team or level of training/proficiency not widely available
  • Comparator (C)
    • Inadequate comparison therapy
    • Use of substandard alternative therapy
  • Outcomes (O)
    • Composite outcomes that mix outcomes of different significance
    • Short-term or surrogate outcomes
  • Setting (S)
    • Standard of care differ markedly from setting of interest
    • Specialty population nor level of care differs from that seen in community
  • Comments

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