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-cTnStandard pathway: Serial hs-cTn at 0, repeat at 2 or 3 then at 6 h for high risk+ TIMI score + History (including: Age, risk factors, symptoms) + ECG
hs-cTnSTAT pathway: Hs-cTn at 0, repeat at 2h and 6h (for high risk) + ECG + HEART score + history (including: Age, risk factors, symptom duration)

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
CategoricalED Visit durationStay < 3h (discharged in < 3h)
  • All Participants
  • ED visit (h)
CategoricalHospitalizationAcute Medical Unit
  • All Participants
  • ED visit
CategoricalHospitalizationCardiology Ward
  • All Participants
  • ED visit
CategoricalHospitalizationOther hospital ward
  • All Participants
  • ED visit
CategoricalHospitalization Disposition to (Acute medical unit, Cardiology ward, and other hospital ward)
  • All Participants
  • ED visit
CategoricalReturn to ED or hospitalRepresentation for any reason
  • All Participants
  • 30 (d)
CategoricalCardiac testingCoronary angiogram, number of tests not patients
  • All Participants
  • 30 (d)
  • In-patient period
CategoricalCardiac testingCTCA (Computed tomography coronary angiogram), number of tests not patients
  • All Participants
  • 30 (d)
  • In-patient period
CategoricalCardiac testingExercise stress test, number of tests not patients
  • All Participants
  • In-patient period
  • 30 (d)
CategoricalCardiac testingMyocardial perfusion scan, number of tests not patients
  • All Participants
  • In-patient period
  • 30 (d)
CategoricalCardiac testingStress echocardiogram, number of tests not patients
  • All Participants
  • In-patient period
  • 30 (d)
CategoricalCardiac testingTransthoracic echocardiogram, number of tests not patients
  • All Participants
  • In-patient period
  • 30 (d)
CategoricalMI, missed/delayed
  • All Participants
  • 30 (d)
CategoricalDeath, all-cause
  • All Participants
  • 30 (d)
ContinuousHospitalization durationLOS (length of stay) in hospital (median duration of observation)
  • All Participants
  • ED visit (h)
CategoricalHospitalizationEmergency department short stay unit
  • All Participants
  • ED visit
CategoricalHospitalizationDirect Discharge from ED
  • All Participants
  • ED visit
CategoricalReturn to ED or hospitalRepresentation in 30 days for chest pain assessment of those with repeat presentation
  • Among those with repeat presentation
  • 30 (d)

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.
ED Visit duration
Universal
Other
Other reference
Hospitalization
Universal
Other
Other reference
Hospitalization
Universal
Other
Other reference
Hospitalization
Universal
Other
Other reference
Hospitalization
Universal
Other
Other reference
Return to ED or hospital
Universal
Other
Other reference
Cardiac testing
Universal
Other
Other reference
Cardiac testing
Universal
Other
Other reference
Cardiac testing
Universal
Other
Other reference
Cardiac testing
Universal
Other
Other reference
Cardiac testing
Universal
Other
Other reference
Cardiac testing
Universal
Other
Other reference
MI, missed/delayed
Universal
Other
Other reference
Death, all-cause
Universal
Other
Other reference
Hospitalization duration
Universal
Other
Other reference
Hospitalization
Universal
Other
Other reference
Hospitalization
Universal
Other
Other reference
Return to ED or hospital
Universal
Other
Other reference
2. MACE components
If a checked component has an asterisk (*), confirm with team before extracting the MACE outcome
ED Visit duration
Hospitalization
Hospitalization
Hospitalization
Hospitalization
Return to ED or hospital
Cardiac testing
Cardiac testing
Cardiac testing
Cardiac testing
Cardiac testing
Cardiac testing
MI, missed/delayed
Death, all-cause
Hospitalization duration
Hospitalization
Hospitalization
Return to ED or hospital

Results

Categorical


ED Visit duration (Stay < 3h (discharged in < 3h))

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
All Arms (ANOVA)

hs-cTn (STAT pathway:...)
vs.
not hs-cTn (Standard...)
ED visit (h)
Total (N analyzed)
Note
Events
Odds Ratio (OR)
Percentage
95% CI low (OR)
Note
95% CI high (OR)
Odds Ratio, Adjusted (adjOR)
95% CI low (adjOR)
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
All Arms (ANOVA)
hs-cTn (STAT pathway:...)
vs.
not hs-cTn (Standard...)

Hospitalization (Acute Medical Unit)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
All Arms (ANOVA)
ED visit
Total (N analyzed)
Note
Events
Odds Ratio (OR)
Percentage
95% CI low (OR)
Note
95% CI high (OR)
Odds Ratio, Adjusted (adjOR)
95% CI low (adjOR)
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
All Arms (ANOVA)

Hospitalization (Cardiology Ward)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
All Arms (ANOVA)
ED visit
Total (N analyzed)
Note
Events
Odds Ratio (OR)
Percentage
95% CI low (OR)
Note
95% CI high (OR)
Odds Ratio, Adjusted (adjOR)
95% CI low (adjOR)
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
All Arms (ANOVA)

Hospitalization (Other hospital ward)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
ED visit
Total (N analyzed)
Note
Events
Odds Ratio (OR)
Percentage
95% CI low (OR)
Note
95% CI high (OR)
Odds Ratio, Adjusted (adjOR)
95% CI low (adjOR)
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn

Hospitalization ( Disposition to (Acute medical unit, Cardiology ward, and other hospital ward))

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
ED visit
Total (N analyzed)
Note
Events
Odds Ratio (OR)
Percentage
95% CI low (OR)
Note
95% CI high (OR)
Odds Ratio, Adjusted (adjOR)
95% CI low (adjOR)
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn

Return to ED or hospital (Representation for any reason)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
All Arms (ANOVA)
30 (d)
Total (N analyzed)
Note
Events
Odds Ratio (OR)
Percentage
95% CI low (OR)
Note
95% CI high (OR)
Odds Ratio, Adjusted (adjOR)
95% CI low (adjOR)
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
All Arms (ANOVA)

Cardiac testing (Coronary angiogram, number of tests not patients )

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
30 (d)
Total (N analyzed)
Note
Events
Odds Ratio (OR)
Note
95% CI low (OR)
95% CI high (OR)
Odds Ratio, Adjusted (adjOR)
95% CI low (adjOR)
95% CI high (adjOR)
p value
In-patient period
Total (N analyzed)
Note
Events
Odds Ratio (OR)
Note
95% CI low (OR)
95% CI high (OR)
Odds Ratio, Adjusted (adjOR)
95% CI low (adjOR)
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn

Cardiac testing (CTCA (Computed tomography coronary angiogram), number of tests not patients)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
30 (d)
Total (N analyzed)
Note
Events
Odds Ratio (OR)
Note
95% CI low (OR)
95% CI high (OR)
Odds Ratio, Adjusted (adjOR)
95% CI low (adjOR)
95% CI high (adjOR)
p value
In-patient period
Total (N analyzed)
Note
Events
Odds Ratio (OR)
Note
95% CI low (OR)
95% CI high (OR)
Odds Ratio, Adjusted (adjOR)
95% CI low (adjOR)
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn

Cardiac testing (Exercise stress test, number of tests not patients)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
In-patient period
Total (N analyzed)
Note
Events
Odds Ratio (OR)
Note
95% CI low (OR)
95% CI high (OR)
Odds Ratio, Adjusted (adjOR)
95% CI low (adjOR)
95% CI high (adjOR)
p value
30 (d)
Total (N analyzed)
Note
Events
Odds Ratio (OR)
Note
95% CI low (OR)
95% CI high (OR)
Odds Ratio, Adjusted (adjOR)
95% CI low (adjOR)
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn

Cardiac testing (Myocardial perfusion scan, number of tests not patients)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
In-patient period
Total (N analyzed)
Note
Events
Odds Ratio (OR)
Note
95% CI low (OR)
95% CI high (OR)
Odds Ratio, Adjusted (adjOR)
95% CI low (adjOR)
95% CI high (adjOR)
p value
30 (d)
Total (N analyzed)
Note
Events
Odds Ratio (OR)
Note
95% CI low (OR)
95% CI high (OR)
Odds Ratio, Adjusted (adjOR)
95% CI low (adjOR)
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn

Cardiac testing (Stress echocardiogram, number of tests not patients)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
In-patient period
Total (N analyzed)
Note
Events
Odds Ratio (OR)
Note
95% CI low (OR)
95% CI high (OR)
Odds Ratio, Adjusted (adjOR)
95% CI low (adjOR)
95% CI high (adjOR)
p value
30 (d)
Total (N analyzed)
Note
Events
Odds Ratio (OR)
Note
95% CI low (OR)
95% CI high (OR)
Odds Ratio, Adjusted (adjOR)
95% CI low (adjOR)
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn

Cardiac testing (Transthoracic echocardiogram, number of tests not patients)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
In-patient period
Total (N analyzed)
Note
Events
Odds Ratio (OR)
Note
95% CI low (OR)
95% CI high (OR)
Odds Ratio, Adjusted (adjOR)
95% CI low (adjOR)
95% CI high (adjOR)
p value
30 (d)
Total (N analyzed)
Note
Events
Odds Ratio (OR)
Note
95% CI low (OR)
95% CI high (OR)
Odds Ratio, Adjusted (adjOR)
95% CI low (adjOR)
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn

MI, missed/delayed

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
30 (d)
Total (N analyzed)
Note
Events
Odds Ratio (OR)
Percentage
95% CI low (OR)
Note
95% CI high (OR)
Odds Ratio, Adjusted (adjOR)
95% CI low (adjOR)
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn

Death, all-cause

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (STAT pathway:...)
vs.
not hs-cTn (Standard...)

hs-cTn (STAT pathway:...)
not hs-cTn (Standard...)
vs.

vs.
30 (d)
Total (N analyzed)
Note
Events
Odds Ratio (OR)
Percentage
95% CI low (OR)
Note
95% CI high (OR)
Odds Ratio, Adjusted (adjOR)
95% CI low (adjOR)
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (STAT pathway:...)
vs.
not hs-cTn (Standard...)
hs-cTn (STAT pathway:...)
not hs-cTn (Standard...)
vs.
vs.

Hospitalization (Emergency department short stay unit)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (STAT pathway:...)
vs.
not hs-cTn (Standard...)
ED visit
Total (N analyzed)
Note
Events
Odds Ratio (OR)
Percentage
95% CI low (OR)
Note
95% CI high (OR)
Odds Ratio, Adjusted (adjOR)
95% CI low (adjOR)
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (STAT pathway:...)
vs.
not hs-cTn (Standard...)

Hospitalization (Direct Discharge from ED)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (STAT pathway:...)
vs.
not hs-cTn (Standard...)
ED visit
Total (N analyzed)
Odds Ratio, Adjusted (adjOR)
Events
95% CI low (adjOR)
Percentage
95% CI high (adjOR)
Note
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (STAT pathway:...)
vs.
not hs-cTn (Standard...)

Return to ED or hospital (Representation in 30 days for chest pain assessment of those with repeat presentation)

Among those with repeat presentation
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
30 (d)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
Note
Odds Ratio, Adjusted (adjOR)
95% CI low (adjOR)
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn

Continuous


Hospitalization duration (LOS (length of stay) in hospital (median duration of observation))

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
vs.

hs-cTn (STAT pathway:...)
vs.
not hs-cTn (Standard...)
ED visit (h)
Total (N analyzed)
p value (Median)
Median
IRR
25th percentile
95% CI low (IRR)
75th percentile
95% CI high (IRR)
Note
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
vs.
hs-cTn (STAT pathway:...)
vs.
not hs-cTn (Standard...)

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