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McCrory DC, Coeytaux RR, Schmit KM, et al. Pulmonary Arterial Hypertension: Screening, Management, and Treatment [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Apr. (Comparative Effectiveness Reviews, No. 117.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

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Pulmonary Arterial Hypertension: Screening, Management, and Treatment [Internet].

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Appendix BData Abstraction Elements

I. Study Characteristics

  • First Author (Last Name) and Year of Publication
  • Additional Articles Used in This Abstraction
  • Study Sites
    • Single Center; Multicenter; Not reported/Unclear
  • Number of Sites
  • Geographical Location (Select all applicable geographic regions)
    • US; Canada; UK; Europe; South America; Central America; Asia; Africa; Australia/New Zealand; Not reported/Unclear; Other (Specify)
  • Funding Source (Check all that apply)
    • Government; Private Foundation; Industry; Not reported; Other (Specify)
  • Enrollment Approach (Check all that apply)
    • Consecutive patients; Convenience sample (not explicitly consecutive); Other (Specify); Not reported/Unclear
  • Study Inclusion and Exclusion Criteria
    • Copy/paste inclusion/exclusion criteria as reported in the article
  • Study Design
    • RCT; Cohort; Other (describe)
  • Study Enrollment/Study Completion
    • Total, Treatment Arm 1, 2, 3, 4
      • Assessed for eligibility (N)
      • Eligible (N)
      • Enrolled/Randomized (N)
      • Completed follow-up (N)
  • Subgroup Analysis (Yes/No)
    • If Yes: Describe the subgroups reported
  • Key Question Applicability
    • KQ1; KQ2; KQ3
      • KQ 1. For patients with suspected pulmonary arterial hypertension (PAH) and asymptomatic patients at high risk for PAH, what is the comparative effectiveness and safety of echocardiography versus echocardiography plus biomarkers as screening modalities before right heart catheterization to establish the diagnosis of PAH (diagnostic accuracy efficacy)?
      • KQ 2. For patients with PAH, what is the comparative effectiveness and safety of (a) echocardiography plus clinical assessment (e.g., functional class, dyspnea, 6-minute walk test) versus biomarkers plus clinical assessment and (b) echocardiography plus clinical assessment versus echocardiography plus biomarkers and clinical assessment in managing PAH (diagnostic thinking efficacy and therapeutic efficacy) and on intermediate-term (≤90 days) and long-term (>90 days) patient outcomes (patient outcome efficacy)?
      • KQ 3. For patients with PAH, what is the comparative effectiveness and safety of monotherapy or combination therapy for PAH using calcium-channel blockers, prostanoids, endothelin receptor antagonists, or phosphodiesterase inhibitors on intermediate-term and long-term patient outcomes?
  • Comments

II. Baseline Characteristics

  • Total, Study Arm 1, Study Arm 2, Study Arm 3, Study Arm 4
    • Patient Population
      • Describe the population for each study arm
    • Number of Subjects
      • N
        • Total
        • Female
        • Male
        • Adults
        • Children
        • Mixed
      • %
        • Female
        • Male
        • Adults
        • Children
        • Mixed
    • Age
      • Mean
        • SD
        • SE
      • Median
        • IQR
    • Ethnicity
      • Hispanic or Latino
        • N
        • %
      • No Hispanic or Latino
        • N
        • %
    • Race
      • Black/African American
        • N
        • %
      • American Indian or Alaska Native
        • N
        • %
      • Asian
        • N
        • %
      • Native Hawaiian or other Pacific Islander
        • N
        • %
      • White
        • N
        • %
      • Multiracial
        • N
        • %
      • Other (Specify)
        • N
        • %
    • Baseline Characteristics
      • BMI
        • Mean
          • SD
          • SE
        • Median
          • IQR
      • WHO Functional Class (N)
        • Class I
        • Class II
        • Class III
        • Class IV
      • NYHA Functional Classification (N)
        • Class I
        • Class II
          Class III
        • Class IV
      • PAH Etiology (N)
        • Idiopathic (1.1)
        • Familial (1.2)
        • Collagen vascular disease (1.3.1)
        • Congenital shunts (1.3.2)
        • Portal HTN (1.3.3)
        • HIV (1.3.4)
        • Drugs/toxins (1.3.5)
        • Venous or capillary disease (1.4.x)
        • Pulmonary HTN of newborn (1.5)
        • Thromboembolic (4.x)
        • Other
      • Disease Duration
        • Mean
          • SD
          • SE
        • Median
          • IQR
      • Obesity (e.g. N with BMI>30)
        • Mean
          • SD
          • SE
        • Median
          • IQR
        • N
      • Prior Treatments (N)
        • Calcium channel blockers
        • Diuretics
        • Digoxin
        • Prostanoids
        • Endothelin antagonists
        • Phosphodiesterase inhibitors
        • Anticoagulants
        • Other
      • Left ventricular ejection fraction (LVEF)
        • Mean
          • SD
          • SE
        • Median
          • IQR
      • Other (Specify)
        • Mean
          • SD
          • SE
        • Median
          • IQR
        • N
  • Comments

III. Intervention Characteristics

  • Study Arm 1, Study Arm 2, Study Arm 3, Study Arm 4
    • Medical Therapy Intervention
      • Amlodipine; Diltiazem; Nifedipine; Verapamil; Epoprostenol; Treprostinil; Iloprost; Bosentan; Ambrisentan; Sildenafil; Tadalafil; Other (Specify); NR/NA
        • Dosage
        • Frequency
        • Duration
          • Administration (oral, inhaled, intravenous, subcutaneous)
    • Describe tests administered
    • Describe biomarkers
    • Describe echocardiographic tests
    • Describe co-treatments
    • Did the study use echocardiography and/or biomarkers?
      • Echocardiography
      • Biomarker(s)
      • Echo + biomarkers
      • NR/NA

IV. Outcomes Definitions

  • Time points
    • Time 1
    • Time 2
    • Time 3
    • Time 4
    • Time 5
  • Echocardiographic parameters (Check all that apply)
    • Right ventricle (RV) size (any RV linear dimension or area by 2D echo)
    • Right atrium (RA) size (any RA linear dimension or area by 2D echo)
    • Fractional area change (FAC)
    • Tricuspid Annular Plane Systolic Excursion (TAPSE)
    • Systolic excursion velocity (S-prime)
    • RIMP/MPI/Tei Index
    • Systolic pulmonary artery pressure (sPAP)
    • Mean pulmonary artery pressure (mPAP)
    • Tricuspid regurgitant (TR) jet velocity
    • Peak TR velocity
    • Right ventricular outflow tract (RVOT) velocity-time integral
    • Right ventricular ejection fraction (RVEF)
    • Pericardial effusion
    • Other (specify; don’t need to include measures of LV function)
  • Right-heart catheterization measures (Check all that apply)
    • Mean pulmonary artery pressure (mPAP)
    • Systolic pulmonary artery pressure (sPAP)
    • Diastolic pulmonary artery pressure (dPAP)
    • Pulmonary vascular resistance (PVR)
    • Cardiac output (CO)
    • Other right-heart catheterization measure (specify)
  • Biomarkers (Check all that apply)
    • Natriuretic peptides (e.g., atrial natriuretic peptide, brain natriuretic peptide)
    • Endothelin-1
    • Uric acid
    • Troponin T
    • Nitric oxide
    • Asymmetric dimethylarginine
    • Cyclic guanosine monophosphate
    • D-dimer
    • Serotonin
    • Other biomarker (specify)
  • Clinical outcomes (Check all that apply)
    • Diagnostic thinking efficacy
    • Therapeutic efficacy (e.g. clinician judgment about diagnosis/prognosis, choice of treatment)
    • Dyspnea
    • 6-minute walk change
    • 6-minute walk absolute score
    • Hospitalization
    • Functional class
    • Quality of life (e.g. SF-36, Minnesota Living With Heart Failure [MLWHF], Cambridge Pulmonary Hypertension Outcome Review [CAMPHOR])
    • Right ventricular dysfunction
    • Right heart failure
    • Mortality
    • Progression to right heart failure
    • Other clinical outcomes (specify)
    • Adverse effect – bleeding
    • Adverse effect – bruising
    • Adverse effect – infection
    • Adverse effect – transient ischemic attack from bubble/contrast echocardiogram
    • Adverse effect – liver function abnormalities
    • Adverse effect – headache
    • Adverse effect – flushing
    • Adverse effect – cough
    • Adverse effect – epistaxis
    • Adverse effect – dyspepsia
    • Adverse effect – diarrhea
    • Adverse effect – peripheral edema
    • Adverse effect – nausea
    • Adverse effect – nasal congestion
    • Adverse effect – dizziness
    • Adverse effect – syncope
    • Adverse effect – hypoxia
    • Adverse effect – increased international normalized ratio
    • Adverse effect – increased prothrombin time
    • Adverse effect – line infection
    • Adverse effect – site pain
    • Adverse effect – abrupt catheter occlusion
    • Adverse effect – other (specify)
  • Comments

V. KQ 1 Outcomes

  • Did the study present other clinical outcomes that will need to be extracted (i.e. bleeding, bruising, etc.)?
  • Echo Parameter
    • RV size
    • RA size
    • Fractional area change
    • TAPSE
    • RIMP/MPI/Tei Index
    • sPAP (systolic pulmonary artery pressure)
    • mPAP (mean pulmonary artery pressure)
    • Tricuspid regurgitant jet velocity
    • Peak tricuspid regurgitant velocity
    • RVOT velocity-time integral
    • RVEF
    • Pericardial effusion
    • Echo Parameter Threshold
    • How was this measure calculated?
    • For how many patients was there no test result for this measure?
  • Reference standard
    • mPAP (mean pulmonary artery pressure)-RH Cath
    • sPAP (systolic pulmonary artery pressure)-RH Cath
    • dPAP (diastolic pulmonary artery pressure)-RH Cath
    • PVR (pulmonary vascular resistance)-RH Cath
    • CO (cardiac output)-RH Cath
    • CI (cardiac Index)
    • RAP (right atrial pressure)
    • PCWP (pulmonary capillary wedge pressure)
    • Reference Standard Threshold
  • Biomarker
    • Natriuretic peptides/BNP
    • Endothelin-1
    • Uric acid
    • Troponin T
    • Nitric oxide
    • Asymmetric dimethylarginine
    • Cyclic guanosine monophosphate
    • D-dimer
    • How was this measure calculated?
    • Biomarker Threshold
    • For how many patients was there no test result for this measure?
  • Data presentation
    • Dichotomous/Continuous/Both
    • If Dichotomous or Both selected:
      • Echo Alone; Echo + Biomarkers; Biomarkers Alone
        • Test positive
          • Disease Positive – True positive N
          • Disease Negative – False positive N
          • Unclear – N unclear
          • Total – Total N
        • Test negative
          • Disease Positive – False negative
          • Disease Negative – True negative
          • Unclear – N unclear
          • Total – Total N
        • Test uncertain
          • Disease Positive – N positive
          • Disease Negative – N negative
          • Unclear – N unclear
          • Total – Total N
        • Total
          • Disease Positive – N positive
          • Disease Negative – N negative
          • Unclear – N unclear
          • Total – Total N
    • If Continuous or Both selected:
      • Echo Alone; Echo + Biomarkers; Biomarkers Alone
        • Table 1
          • N for Analysis
          • Pearson product-moment correlation (r)
          • r2
          • Bland-Altman analysis
          • Variability
            • Standard Error(SE)/Standard Deviation(SD)/Other(Specify)
          • p-value between test and reference standard
          • Time interval between test and reference standard
      • Table 2
        • Disease Positive
          • N Positive
          • Mean
            • SD
            • SE
          • Median
            • IQR
        • Disease Negative
          • N Negative
          • Mean
            • SD
            • SE
          • Median
            • IQR
        • Diagnosis Unclear
          • N Unclear
          • Mean
            • SD
            • SE
          • Median
            • IQR
        • Other
          • N
          • Mean
            • SD
            • SE
          • Median
            • IQR
        • p-value between Test and Reference Standard

VI. KQ 2 Outcomes

  • Did the study report other clinical outcomes that will need to be abstracted?(Yes/No)
  • Table 1, Table 2, Table 3, Table 4, Table 5
    • Timing
      • Baseline
      • Intermediate term >30 days and ≤ 1 year
        • 1 month/2 months/3 months/4 months/6 months/1 year/Other (Specify)
      • Long-term > 1 year
        • 2 years/3 years/4 years/5 years/Other (Specify)
    • Intervention
      • Intervention 1
        • RV size
        • RA size
        • Fractional area change
        • TAPSE
        • RIMP/MPI/Tei Index
        • sPAP (systolic pulmonary artery pressure)
        • mPAP (mean pulmonary artery pressure)
        • Tricuspid regurgitant jet velocity
        • Peak tricuspid regurgitant velocity
        • RVOT velocity-time integral
        • RVEF
        • Pericardial effusion
        • RVSP
        • Natriuretic peptides/BNP
        • Endothelin-1
        • Uric acid
        • Troponin T
        • Nitric oxide
        • Asymmetric dimethylarginine
        • Cyclic guanosine monophosphate
        • D-dimer
      • Describe Intervention 1
      • Intervention 2
        • RV size
        • RA size
        • Fractional area change
        • TAPSE
        • RIMP/MPI/Tei Index
        • sPAP (systolic pulmonary artery pressure)
        • mPAP (mean pulmonary artery pressure)
        • Tricuspid regurgitant jet velocity
        • Peak tricuspid regurgitant velocity
        • RVOT velocity-time integral
        • RVEF
        • Pericardial effusion
        • RVSP
        • Natriuretic peptides/BNP
        • Endothelin-1
        • Uric acid
        • Troponin T
        • Nitric oxide
        • Asymmetric dimethylarginine
        • Cyclic guanosine monophosphate
        • D-dimer
        • NA
      • Describe Intervention 2
    • Comparator
      • Comparator 1
        • RV size
        • RA size
        • Fractional area change
        • TAPSE
        • RIMP/MPI/Tei Index
        • sPAP (systolic pulmonary artery pressure)
        • mPAP (mean pulmonary artery pressure)
        • Tricuspid regurgitant jet velocity
        • Peak tricuspid regurgitant velocity
        • RVOT velocity-time integral
        • RVEF
        • Pericardial effusion
        • RVSP
        • Natriuretic peptides/BNP
        • Endothelin-1
        • Uric acid
        • Troponin T
        • Nitric oxide
        • Asymmetric dimethylarginine
        • Cyclic guanosine monophosphate
        • D-dimer
        • RH cath-mPAP
        • RH cath-sPAP
        • RH cath-dPAP
        • RH cath-PVR
        • RH cath-CO
        • Cardiac index (CI)
        • Right atrial pressure (RAP)
        • Pulmonary capillary wedge pressure (PCWP)
        • Dyspnea
        • 6 minute walk change
        • 6 minute walk (absolute)
        • Hospitalization
        • Functional class
        • Quality of life
        • Right ventricular dysfunction
        • Right heart failure/progression to right heart failure
        • Mortality
        • Transplant
        • Adverse effect – bleeding
        • Adverse effect – bruising
        • Adverse effect – infection
        • Adverse effect – transient ischemic attack
        • Adverse effect – liver function
        • Adverse effect – headache
        • Adverse effect – flushing
        • Adverse effect – cough
        • Adverse effect – epistaxis
        • Adverse effect – dyspepsia
        • Adverse effect – diarrhea
        • Adverse effect – peripheral edema
        • Adverse effect – nausea
        • Adverse effect – nasal congestion
        • Adverse effect – dizziness
        • Adverse effect – syncope
        • Adverse effect – hypoxia
        • Adverse effect – increased INR
        • Adverse effect – line infection
        • Adverse effect – site pain
        • Adverse effect – abrupt catheter occlusion
        • Adverse effect – rash
        • Adverse effect – jaw pain
        • Composite outcome (Specify)
      • Describe Comparator 1
      • Comparator 2
        • RV size
        • RA size
        • Fractional area change
        • TAPSE
        • RIMP/MPI/Tei Index
        • sPAP (systolic pulmonary artery pressure)
        • mPAP (mean pulmonary artery pressure)
        • Tricuspid regurgitant jet velocity
        • Peak tricuspid regurgitant velocity
        • RVOT velocity-time integral
        • RVEF
        • Pericardial effusion
        • RVSP
        • Natriuretic peptides/BNP
        • Endothelin-1
        • Uric acid
        • Troponin T
        • Nitric oxide
        • Asymmetric dimethylarginine
        • Cyclic guanosine monophosphate
        • D-dimer
        • RH cath-mPAP
        • RH cath-sPAP
        • RH cath-dPAP
        • RH cath-PVR
        • RH cath-CO
        • Cardiac index (CI)
        • Right atrial pressure (RAP)
        • Pulmonary capillary wedge pressure (PCWP)
        • Dyspnea
        • 6 minute walk change
        • 6 minute walk (absolute)
        • Hospitalization
        • Functional class
        • Quality of life
        • Right ventricular dysfunction
        • Right heart failure/progression to right heart failure
        • Mortality
        • Transplant
        • Adverse effect – bleeding
        • Adverse effect – bruising
        • Adverse effect – infection
        • Adverse effect – transient ischemic attack
        • Adverse effect – liver function
        • Adverse effect – headache
        • Adverse effect – flushing
        • Adverse effect – cough
        • Adverse effect – epistaxis
        • Adverse effect – dyspepsia
        • Adverse effect – diarrhea
        • Adverse effect – peripheral edema
        • Adverse effect – nausea
        • Adverse effect – nasal congestion
        • Adverse effect – dizziness
        • Adverse effect – syncope
        • Adverse effect – hypoxia
        • Adverse effect – increased INR
        • Adverse effect – line infection
        • Adverse effect – site pain
        • Adverse effect – abrupt catheter occlusion
        • Adverse effect – rash
        • Adverse effect – jaw pain
        • Composite outcome (Specify)
      • Describe Comparator 2
    • Population and N for Analysis
      • Intervention
        • Population
        • N for Analysis
      • Comparator
        • Population
        • N for Analysis
    • Result
      • Mean
      • Median
      • Number Patients with Outcome
      • % Patients with Outcome
      • Relative Risk (RR)
      • Relative Hazard (HR)
      • Odds Ratio (OR)
      • Risk difference
      • Correlation
      • Other (Specify)
    • Variability
      • Standard Error (SE)
      • Standard Deviation (SD)
      • Other (Specify)
    • Confidence interval (CI) or Interquartile Range (IQR)
      • 95% CI/Other % CI (Specify)/IQR
        • LL (25% if IQR)
        • UL (75% if IQR)
    • p-value between treatment groups
  • Describe the diagnostic thinking efficacy
  • Describe the therapeutic efficacy
  • Comments

VII. Clinical Outcomes

  • Outcome reported on this form
    • Dyspnea
    • Six minute walk change
    • Six minute walk (absolute)
    • Hospitalization
    • Functional class
    • Quality of life (SF-36, MLWH, CAMPHOR)
    • Right ventricular dysfunction
    • Right heart failure/progression to right heart failure
    • Mortality
    • Transplant/progression to transplant
    • Adverse effect – bleeding
    • Adverse effect – bruising
    • Adverse effect – infection
    • Adverse effect – transient ischemic attack
    • Adverse effect – liver function abnormalities
    • Adverse effect – headache
    • Adverse effect – flushing
    • Adverse effect – cough
    • Adverse effect – epistaxis
    • Adverse effect – dyspepsia
    • Adverse effect – diarrhea
    • Adverse effect – peripheral edema
    • Adverse effect – nausea
    • Adverse effect – nasal congestion
    • Adverse effect – dizziness
    • Adverse effect – syncope
    • Adverse effect – hypoxia
    • Adverse effect – increased international normalized ratio
    • Adverse effect – line infection
    • Adverse effect – site pain
    • Adverse effect – abrupt catheter occlusion
    • Adverse effect – jaw pain
    • Adverse effect – rash
    • Composite outcome
      • Composite outcome consisted of
    • RV size
    • RA size
    • Fractional area change
    • TAPSE
    • RIMP/MPI/Tei Index
    • sPAP
    • mPAP
    • TR jet velocity
    • Peak TR velocity/RVOT velocity-time interval
    • RVEF
    • Pericardial Effusion
    • RVSP
    • Natriuretic peptides/BNP
    • Endothelin-1
    • Uric acid
    • Troponin T
    • Nitric oxide
    • Asymmetric dimethylarginine
    • c-GMP
    • D-dimer
    • RH cath – sPAP
    • RH cath – mPAP
    • RH cath – dPAP
    • RH cath –PVR
    • RH cath – CO
    • Cardiac Index (CI)
    • Right atrial pressure (RAP)
    • Pulmonary capillary wedge pressure (PCWP)
  • Additional/alternate outcome name (if applicable)
  • Authors’ definition of outcome (if applicable)
  • Table 1, 2, 3, 4, 5
    • Timing
      • Baseline
      • Intermediate term > 30 days and ≤ 1 year
        • 1 month/2 months/3 months/4 months/6 months/1 year/Other (Specify)
      • Long-term > 1 year
        • 2 years/3 years/4 years/5 years/Other (Specify)
    • Adjustments
      • Results are not adjusted
      • Age
      • Sex
      • Race/ethnicity
      • Comorbidity(ies) (Specify)
      • Body weight/BMI
      • Risk factors
      • PAH classification
      • Other (specify all)
    • Group
      • Study Arm 1, 2, 3, 4
    • N for Analysis
    • Result
      • Mean
      • Median
      • Number Patients with Outcome
      • % Patients with Outcome
      • Relative Risk (RR)
      • Relative Hazard (HR)
      • Odds Ratio (OR)
      • Risk difference
      • Other (Specify)
    • Variability
      • Standard Error (SE)
      • Standard Deviation (SD)
      • Other (Specify)
    • Confidence Interval (CI) or Interquartile Range (IQR)
      • 95% CI/Other % CI (Specify)/IQR
        • LL (25% if IQR)
        • UL (75% if IQR)
    • p-value between treatment groups
    • Reference group (for comparisons between treatment groups)
  • Comments

VIII. Quality

  • Was this an accuracy study? (Yes/No)
    • If Yes:
      • Population (P)
        • Was a consecutive or random sample of patients unrolled? (Yes/No/Unclear)
        • Was a case-control design avoided? (Yes/No/Unclear)
        • Did the study avoid inappropriate exclusions? (Yes/No/Unclear)
        • Could the selection of patients have introduced bias? (Yes/No/Unclear)
      • Interventions (I)
        • Were the index test results interpreted without knowledge of the results of the reference standard? (Yes/No/Unclear)
        • If a threshold was used, was it pre-specified? (Yes/No/Unclear)
        • Could the conduct or interpretation of the index test have introduced bias? (Yes/No/Unclear)
      • Comparators (C)
        • Is the reference standard likely to correctly classify the target condition? (Yes/No/Unclear)
        • Were the reference standard results interpreted without knowledge of the results of the index test? (Yes/No/Unclear)
        • Could the reference standard, its conduct, or its interpretation have introduced bias? (Yes/No/Unclear)
      • Timing (T)
        • Was there an appropriate interval between index test(s) and reference standard? (Yes/No/Unclear)
        • Did all patients receive a reference standard? (Yes/No/Unclear)
        • Did all patients receive the same reference standard? (Yes/No/Unclear)
        • Were all patients included in the analysis? (Yes/No/Unclear)
        • Could the patient flow have introduced bias? (Yes/No/Unclear)
      • Overall study rating (Good/Fair/Poor)
        • If Fair: Describe why the study was given a ‘Fair’ rating
        • If Poor: Describe why the study was given a ‘Poor’ rating
    • If No:
      • Was this study randomized? (Yes/No)
        • If Yes:
          • Were study subjects randomized? (Yes/No/Unclear)
          • Was the randomization process described? (Yes/No/Unclear)
          • Was the outcome assessor blinded to study assignment? (Yes/No/Unclear)
          • Were patients blinded to study intervention? (Yes/No/Unclear)
          • Were results adjusted for clustering? (Yes/No/Unclear)
          • Were measures of outcomes based on validated procedures or instruments? (Yes/No/Unclear)
          • Conducted an intent-to-treat analysis? (Yes/No/Unclear)
          • Were all outcomes reported (i.e. was there evidence of selective outcome reporting)? (Yes/No/Unclear)
          • Were incomplete data adequately addressed? (Yes/No/Unclear)
          • Was there adequate power (either based on pre-study or post-hoc power calculations [80% power for primary outcome])? (Yes/No/Unclear)
          • Were systematic differences observed in baseline characteristics and prognostic factors across the groups compared? (Yes/No/Unclear)
          • Were comparable groups maintained? (Yes/No/Unclear)
          • Was there absence of potential important conflict-of-interest? (Yes/No/Unclear)
        • If No:
          • Basic Design
            • Is the study design prospective, retrospective, or mixed? (Prospective/Mixed/Retrospective/Cannot determine)
          • Selection Bias
            • Inclusion/Exclusion Criteria
              • Are the inclusion/exclusion criteria clearly stated (does not require the reader to infer)? (Yes/Partially/No)
              • Did the study apply inclusion/exclusion criteria uniformly to all comparison groups? (Yes/Partially/No/NA)
            • Recruitment
              • Did the strategy for recruiting participants into the study differ across study groups? (Yes/No/Cannot determine/NA)
            • Baseline characteristics similar or appropriate adjusted analysis
              • Are key characteristics of study participants similar between intervention and control groups? If not similar, did the analysis appropriately adjust for important differences? (Yes/Partially/No/Insufficient reporting to be able to determine/NA)
            • Comparison Group
              • Is the selection of the comparison group appropriate? (Yes/No/Cannot determine/NA)
          • Performance Bias
            • Intervention implementation
              • What is the level of detail in describing the intervention or exposure?
                • High; very clear, all PI-required details provided
                • Medium; somewhat clear, majority of PI-required details provided
                • Low; unclear, many PI-required details missing
            • Concurrent/concomitant interventions
              • Did researchers isolate the impact from a concurrent intervention or unintended exposure that might bias the results, e.g., through multivariate analysis, stratification, or subgroup analysis? (Yes/Partially/Not described/NA)
          • Attrition Bias
            • Equality of length of follow-up for participants
              • In cohort studies, is the length of follow-up different between the groups? (Yes/No or cannot determine/NA)
            • Completeness of follow-up
              • Was there a high rate of differential or overall attrition? (Yes/No/Cannot determine)
            • Attrition affecting participant composition
              • Did attrition result in a difference in group characteristics between baseline and follow-up? (Yes/No/Cannot determine)
            • Any attempt to balance
              • Any attempt to balance the allocation between the groups? (Yes/No/Cannot determine/NA)
            • Intention-to-treat analysis
              • Is the analysis conducted on an intention-to-treat (ITT) basis, that is, the intervention allocation status rather than the actual intervention received? (Yes/No/Cannot determine/NA)
          • Detection Bias
            • Source of information re: outcomes
              • Are clinical outcomes (e.g. hemodynamic parameters, right heart failure or right ventricular dysfunction, and mortality) assessed using valid and reliable measures and implemented consistently across all study participants? (Yes/No/Cannot determine/NA)
              • Are patient-reported outcomes (e.g., symptom scores, quality of life) assessed using valid and reliable measures and implemented consistently across all study participants? (Yes/No/Cannot determine/NA)
              • Are functional capacity outcomes (e.g. 6-minute walk test, functional class) assessed using valid and reliable measures, implemented consistently across all study participants? (Yes/No/Cannot determine/NA)
          • Reporting Bias
            • Are any important primary outcomes missing from the results? (Yes/No/Cannot determine/Primary outcomes not pre-specified)
          • Other risk of bias issues
            • Are the statistical methods used to assess the primary outcomes appropriate to the data? (Yes/Partially/No/Cannot determine)
          • Power and sample size
            • Did the authors report conducting a power analysis or some other basis for determining the adequacy of study group sizes for the primary outcome(s) being abstracted? (Yes/No/NA)
          • Overall rating of the study (Good/Fair/Poor)
            • If Fair: Describe why the study was given a ‘Fair’ rating
            • If Poor: Describe why the study was given a ‘Poor’ rating

IX. Applicability

  • Population (P)
    • Is there concern that the study population is inadequately described to assess the applicability of this study? (Yes/No)
    • Is there concern that participants are at widely differing points in natural history of disease? (Yes/No)
    • Is there concern that participants have widely differing degrees of disease severity? (Yes/No)
    • Is there concern that the included patients do not match the review question? (Yes/No)
    • Did the study exclude participants with other conditions that might be easily confused with PAH such as PH due to heart failure, thrombotic disease, COPD? (KQ1 only) (Yes/No)
    • Did the study include patients with a wide variety of conditions in addition to the target population? (Yes/No)
    • Did the study selectively recruit participants who demonstrated a history of favorable or unfavorable response to drug or other interventions for the condition? (KQ2 and KQ3 only) (Yes/No)
  • Intervention (I)
    • Is there concern that the index test, its conduct, or interpretation differ from the review question? (KQ1,2) (Yes/No)
    • Is there concern that equipment or operator level of training/proficiency is not widely available? (KQ1, KQ2) (Yes/No)
    • Is there concern that the intervention (active arm) is not similar to that used in routine clinical practice? (Yes/No)
  • Comparator (C)
    • Is there concern that the target condition as defined by the reference standard does not match the review question? (Yes/No)
  • Outcomes (O)
    • Is there concern that cointerventions/treatments do not adequately reflect routine clinical practice? (Yes/No)
    • If surrogate outcomes were used, is there concern that they are not sufficiently clinically relevant? (Yes/No)
    • Is there concern that outcomes are not measured for sufficiently long duration of treatment? (KQ2, KQ3) (Yes/No)
    • Is there concern that potential adverse events associated with testing (KQ1,2) or treatment (KQ2,3) were not measured or reported? (Yes/No)
  • Setting (S)
    • Is there concern that the care delivery setting is widely divergent from the current typical US setting? (Yes/No)
  • Did the study have significant issues with applicability? (Yes/No)
  • Comments

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