Extraction form for project: ESP Troponin ADPs

Design Details

1. Cohort name
Cohort, not ADP, name
2. Protocol number (eg, NCT)
3. Copublications
List other records that were extracted with this primary articles. Eg, PMIDs or other identifiers
4. Study design
5. Study years
Just years. Not publication year. Years of study. You may need to estimate. Use tilde (~) if you're approximating. If not reported, put "< ####" (the publication or submission year).
StartEnd
6. Funding
Include provision of materials (eg, cTn labs) from industry as industry funding
7. Country/ies
NR should rarely if ever be selected
8. Setting
9. Centers
If Unclear, add a note why
10. Inclusion criteria
ACS row = Eligibility criteria specific to acute coronary syndrome symptoms/signs. Age/Gender = criteria specific to age/gender. Prior CVD = restriction based on prior cardiovascular disease, event, or procedure. Other = other inclusion criteria. Skip rows that do not pertain. Be concise.
ACS
Age
Gender
Prior CVD
Other
11. Exclusion criteria
Prior CVD = exclusion based on prior cardiovascular disease, event, or procedure. Other = other exclusion criteria. Skip rows that do not pertain. Be concise.
STEMI
Prior CVD
Comorbidity
Other
12. Special/Atypical population
Highlight if this is a specific group of patients. Skip if no particular relevant exclusion criteria
13. Comments/Notes

Arms

Arm NameArm Description
not hs-cTnPre-introduction of hs-TnT: Standard conventional cTnT + GRACE score
hs-cTn Post-introduction of hs-TnT (following White algorithm): Hs-cTnT at 0, 3, 6h or as long as clinically indicated + GRACE score

Arm Details

1. hs-cTn info
Click NR checkboxes in each row with no reported data
not hs-cTn
DataNR
Test name
Manufacturer
Generation
Limit of detection (ng/L)
Comment/Note
99th %ile
hs-cTn
DataNR
Test name
Manufacturer
Generation
Limit of detection (ng/L)
Comment/Note
99th %ile

Sample Characteristics

1. N Enrolled
2. Age
3. % Male
4. Race/Ethnicity, %
White
White, Non-Hispanic
Black
Hispanic/Latino
Asian (any)
East Asian
South Asian
Other 1
Other 2
Other 3
NR
5. Are there significant differences (statistical or clinical) between the two groups?
6. History of Cardiovascular Disease, %
peripheral arterial disease
Stroke/TIA
Prior MI
prior revascularization (eg., CABG, PCI)
History of Cardiovascular Disease
7. Risk Factors for Cardiovascular Disease, %
Comments
Hypertension
Diabetes
Smoking Histrory
BMI/obesity
Family History
Hyperlipidemia
8. Risk Score
Enter risk score name (eg Heart), mean (SD) or thresholds and proportions
Name Risk ScoreThresholdProportion, %Mean (SD)Comment
Risk Score 1
Risk Score 2
Risk Score 3
Risk Score 4
9. Notes/Comments

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalHospitalizationNot-Admitted patients
  • All Participants
  • ED visit
CategoricalHospitalizationAdmitted patients
  • All Participants
  • ED visit
CategoricalDeath, all-causeIn-hospital
  • All Participants
  • Hospitalization
CategoricalDeath, all-cause30 day mortality
  • All Participants
  • Admitted patients subset
  • Not-admitted patients subset
  • 30 (d)
CategoricalDeath, cardiovascularIn-hospital outcome
  • All Participants
  • Hospitalization
CategoricalDeath, cardiovascular30-day mortality
  • All Participants
  • Admitted patients subset
  • Not-admitted patients subset
  • 30 (d)
CategoricalCardiac testingCoronary angiography
  • All Participants
  • Hospitalization
CategoricalCardiac revascularizationPrimary PCI in STE-ACS patients
  • STE-ACS patients
  • Hospitalization
CategoricalCardiac revascularizationPCI
  • All Participants
  • Hospitalization
CategoricalCardiac revascularizationCABG
  • All Participants
  • Hospitalization
CategoricalMACERe-infarction
  • All Participants
  • Hospitalization
CategoricalMACEStroke
  • All Participants
  • Hospitalization
CategoricalMACEUnstable angina as final diagnosis
  • All Participants
  • High sensitivity assay using at least one value above the URL (99th percentile)
  • At hospital discharge
CategoricalMACECardiac disease other than ACS as final diagnosis (including stable angina, heart failure, myopericarditis, arrhythmia, pulmonary embolism, acute aortic syndrome, hypertensive crisis)
  • All Participants
  • At hospital discharge
CategoricalMACENon-cardiac disease as final diagnosis
  • All Participants
  • At hospital discharge
CategoricalMI, anyNSTEMI as final diagnosis
  • All Participants
  • High sensitivity assay using at least one value above the URL (99th percentile)
  • At hospital discharge
CategoricalMI, anySTEMI
  • All Participants
  • At hospital discharge
CategoricalMI, any AMI incidence as final diagnosis
  • All Participants
  • At hospital discharge

Outcome Details

1. MI definition
Universal definitions refer to ESC/ACC/AHA/WHF (or Global MI) task forces. If an Other definition, provide details in 2nd row and the cited reference for their definition in the 3rd row.
Hospitalization
Universal
Other
Other reference
Hospitalization
Universal
Other
Other reference
Death, all-cause
Universal
Other
Other reference
Death, all-cause
Universal
Other
Other reference
Death, cardiovascular
Universal
Other
Other reference
Death, cardiovascular
Universal
Other
Other reference
Cardiac testing
Universal
Other
Other reference
Cardiac revascularization
Universal
Other
Other reference
Cardiac revascularization
Universal
Other
Other reference
Cardiac revascularization
Universal
Other
Other reference
MACE
Universal
Other
Other reference
MACE
Universal
Other
Other reference
MACE
Universal
Other
Other reference
MACE
Universal
Other
Other reference
MACE
Universal
Other
Other reference
MI, any
Universal
Other
Other reference
MI, any
Universal
Other
Other reference
MI, any
Universal
Other
Other reference
2. MACE components
If a checked component has an asterisk (*), confirm with team before extracting the MACE outcome
Hospitalization
Hospitalization
Death, all-cause
Death, all-cause
Death, cardiovascular
Death, cardiovascular
Cardiac testing
Cardiac revascularization
Cardiac revascularization
Cardiac revascularization
MACE
MACE
MACE
MACE
MACE
MI, any
MI, any
MI, any

Results

Categorical


Hospitalization (Not-Admitted patients)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
ED visit
Total (N analyzed)
p value (at least 1 value > URL) vs not hs-TnT
Events
p value (at least 1 value > URL) vs hs-TnT
Percentage
Increase%
Note
Comment
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn

Hospitalization (Admitted patients)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
ED visit
Total (N analyzed)
p value (at least 1 value > URL) vs not hs-TnT
Events
p value (at least 1 value > URL) vs hs-TnT
Percentage
Increase%
Note
Comment
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn

Death, all-cause (In-hospital)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)
Hospitalization
Total (N analyzed)
p value (at least 1 value > URL) vs not hs-TnT
Events
p value (at least 1 value > URL) vs hs-TnT
Percentage
Increase%
Note
Comment
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)

Death, all-cause (30 day mortality)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)
30 (d)
Total (N analyzed)
p value (at least 1 value > URL) vs not hs-TnT
Events
p value (at least 1 value > URL) vs hs-TnT
Percentage
Increase%
Note
Comment
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)
Admitted patients subset
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)
30 (d)
Total (N analyzed)
p value (at least 1 value > URL) vs not hs-TnT
Events
p value (at least 1 value > URL) vs hs-TnT
Percentage
Increase%
Note
Comment
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)
Not-admitted patients subset
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
30 (d)
Total (N analyzed)
p value (at least 1 value > URL) vs not hs-TnT
Events
p value (at least 1 value > URL) vs hs-TnT
Percentage
Increase%
Note
Comment
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn

Death, cardiovascular (In-hospital outcome)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)
Hospitalization
Total (N analyzed)
Comment
Events
p value
Percentage
Note
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)

Death, cardiovascular (30-day mortality)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)
30 (d)
Total (N analyzed)
p value (at least 1 value > URL) vs not hs-TnT
Events
p value (at least 1 value > URL) vs hs-TnT
Percentage
Increase%
Note
Comment
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)
Admitted patients subset
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
vs.
30 (d)
Total (N analyzed)
p value (at least 1 value > URL) vs not hs-TnT
Events
p value (at least 1 value > URL) vs hs-TnT
Percentage
Increase%
Note
Comment
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
vs.
Not-admitted patients subset
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
30 (d)
Total (N analyzed)
p value (at least 1 value > URL) vs not hs-TnT
Events
p value (at least 1 value > URL) vs hs-TnT
Percentage
Increase%
Note
Comment
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn

Cardiac testing (Coronary angiography)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)
Hospitalization
Total (N analyzed)
p value (at least 1 value > URL) vs not hs-TnT
Events
p value (at least 1 value > URL) vs hs-TnT
Percentage
Increase%
Note
Comment
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)

Cardiac revascularization (Primary PCI in STE-ACS patients)

STE-ACS patients
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-introduct...)
vs.
hs-cTn (...)
Hospitalization
Total (N analyzed)
p value (at least 1 value > URL) vs not hs-TnT
Events
p value (at least 1 value > URL) vs hs-TnT
Percentage
Increase%
Note
Comment
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-introduct...)
vs.
hs-cTn (...)

Cardiac revascularization (PCI)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)
Hospitalization
Total (N analyzed)
p value (at least 1 value > URL) vs not hs-TnT
Events
p value (at least 1 value > URL) vs hs-TnT
Percentage
Increase%
Note
Comment
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)

Cardiac revascularization (CABG)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)
Hospitalization
Total (N analyzed)
p value (at least 1 value > URL) vs not hs-TnT
Events
p value (at least 1 value > URL) vs hs-TnT
Percentage
Increase%
Note
Comment
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)

MACE (Re-infarction)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)
Hospitalization
Total (N analyzed)
p value (at least 1 value > URL) vs not hs-TnT
Events
p value (at least 1 value > URL) vs hs-TnT
Percentage
Increase%
Note
Comment
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)

MACE (Stroke)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)
Hospitalization
Total (N analyzed)
p value (at least 1 value > URL) vs not hs-TnT
Events
p value (at least 1 value > URL) vs hs-TnT
Percentage
Increase%
Note
Comment
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)

MACE (Unstable angina as final diagnosis)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)
At hospital discharge
Total (N analyzed)
p value (at least 1 value > URL) vs not hs-TnT
Events
p value (at least 1 value > URL) vs hs-TnT
Percentage
Increase%
Note
Comment
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)
High sensitivity assay using at least one value above the URL (99th percentile)
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
All Arms (ANOVA)
At hospital discharge
Total (N analyzed)
p value (at least 1 value > URL) vs not hs-TnT
Events
p value (at least 1 value > URL) vs hs-TnT
Percentage
Increase%
Note
Comment
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
All Arms (ANOVA)

MACE (Cardiac disease other than ACS as final diagnosis (including stable angina, heart failure, myopericarditis, arrhythmia, pulmonary embolism, acute aortic syndrome, hypertensive crisis) )

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)
At hospital discharge
Total (N analyzed)
p value (at least 1 value > URL) vs not hs-TnT
Events
p value (at least 1 value > URL) vs hs-TnT
Percentage
Increase%
Note
Comment
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)

MACE (Non-cardiac disease as final diagnosis)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)
At hospital discharge
Total (N analyzed)
p value (at least 1 value > URL) vs not hs-TnT
Events
p value (at least 1 value > URL) vs hs-TnT
Percentage
Increase%
Note
Comment
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)

MI, any (NSTEMI as final diagnosis)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)
At hospital discharge
Total (N analyzed)
p value (at least 1 value > URL) vs not hs-TnT
Events
p value (at least 1 value > URL) vs hs-TnT
Percentage
Increase%
Note
Comment
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)
High sensitivity assay using at least one value above the URL (99th percentile)
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
All Arms (ANOVA)
At hospital discharge
Total (N analyzed)
p value (at least 1 value > URL) vs not hs-TnT
Events
p value (at least 1 value > URL) vs hs-TnT
Percentage
Increase%
Note
Comment
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
All Arms (ANOVA)

MI, any (STEMI)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)
At hospital discharge
Total (N analyzed)
p value (at least 1 value > URL) vs not hs-TnT
Events
p value (at least 1 value > URL) vs hs-TnT
Percentage
Increase%
Note
Comment
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)

MI, any ( AMI incidence as final diagnosis)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)
At hospital discharge
Total (N analyzed)
p value (at least 1 value > URL) vs not hs-TnT
Events
p value (at least 1 value > URL) vs hs-TnT
Percentage
Increase%
Note
Comment
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (...)
vs.
not hs-cTn (Pre-introduct...)

Study Risk of Bias

1. Design
2. Clarity: Discrepancies
Was the article free of discrepancies (eg, between text and tables)? Add note if No (High concern)
3. Clarity: Population
Were patient eligibility criteria sufficiently clear? Add note if No (High concern).
4. Clarity: Intervention/Comparator
Were the ADP (and comparator) sufficiently clear? Add note if No (High concern)
5. Clarity: Outcomes
Were outcomes adequately defined without problem? Add note if No (High concern). Not every outcome requires an explicit definition (e.g., duration of ED stay).
6. Clarity: Setting
Was the setting sufficiently clearly defined? (Eg, Do we know the hospital (and ED) type?) Add note if No (High concern).
7. Missing data
Were there missing results data for ANY patients for outcomes that occurred in ED or hospital? Were there missing results data for >20% of patients (or imbalance between study groups) for outcomes that occurred after ED/hospital discharge? Add Note if Yes
8. Outcome ascertainment
9. RCT: Randomization & Allocation Concealment
Was there inadequate randomization method or allocation concealment? Whether randomization was done at the level of the ED or the patient, answer No, unless there's an obvious flaw. If Yes, add note.
10. Observational: Cohort representativeness
Eligible patients having ADP were all selected or a random selection was selected. No concerns about biased selection of ADP patients. Add note if No (high RoB)
11. NRCI: Comparator representativeness
Comparator group (or ED) was sufficiently similar (and selected patients were all included or a random sample were included). Add note if No (high RoB)
12. NRCI: Adjustment for confounders