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-implementation: 2015 ESC Hs-cTnT at 0, 1, 3h (Hs-cTnT and copeptin in small proportion of ruled-out patients) + ECG + history + Risk factors or GRACE
hs-cTnPost-implementation: ESC 0/1-h hs-TnT algorithm + Risk factors or GRACE +clinical assessment (History, physical examination, ECG, pulse oximetry, blood test (including copeptin)

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
ContinuousED Visit durationLength of Stay (hours)
  • All Participants
  • ED visit (h)
CategoricalHospitalizationDischarge rate (not hospitalized)
  • All Participants
  • ED visit
CategoricalCardiac testingStress-ECG
  • All Participants after rule-out and direct discharge
  • 30 (d)
CategoricalCardiac testingStress-Echo
  • All Participants after rule-out and direct discharge
  • 30 (d)
CategoricalCardiac testingStress-MRI
  • All Participants after rule-out and direct discharge
  • 30 (d)
CategoricalCardiac testingTriple rule-out CT
  • All Participants after rule-out and direct discharge
  • 30 (d)
CategoricalCardiac testingMRI
  • All Participants after rule-out and direct discharge
  • 30 (d)
CategoricalCardiac testingTTE/TEE (transthoracic echocardiography; transesophageal echocardiography)
  • All Participants after rule-out and direct discharge
  • 30 (d)
CategoricalDeath, all-causeMortality at 30 days
  • All Participants
  • 30 (d)
CategoricalCardiac testingCoronary angiography
  • All Participants
  • 30 (d)
CategoricalCardiac revascularizationPCI: Coronary angiography with PCI
  • Among those who underwent coronary angiography
  • 30 (d)
CategoricalCardiac revascularizationPCI: Coronary angiography without PCI
  • Among those who underwent coronary angiography
  • 30 (d)
CategoricalImplementation / Adherence Pre-post change in 0/1 Algorithm
  • All Participants
  • ED visit
CategoricalImplementation / Adherence Pre-post change 0/3 Algorithm
  • All Participants
  • ED visit
CategoricalCardiac testingCoronary angiography within 30 days
  • Among those who underwent coronary angiography
  • < 6 (h)
  • < 72 (h)
CategoricalImplementation / Adherence Rule-out rate by implementation
  • All Participants
  • ED visit
CategoricalImplementation / Adherence Rule-in rate by implementation
  • All Participants
  • ED visit
CategoricalImplementation / Adherence Observational zone rate by implementation
  • All Participants
  • ED visit

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
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
Death, all-cause
Universal
Other
Other reference
Cardiac testing
Universal
Other
Other reference
Cardiac revascularization
Universal
Other
Other reference
Cardiac revascularization
Universal
Other
Other reference
Implementation / Adherence
Universal
Other
Other reference
Implementation / Adherence
Universal
Other
Other reference
Cardiac testing
Universal
Other
Other reference
Implementation / Adherence
Universal
Other
Other reference
Implementation / Adherence
Universal
Other
Other reference
Implementation / Adherence
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
Cardiac testing
Cardiac testing
Cardiac testing
Cardiac testing
Cardiac testing
Cardiac testing
Death, all-cause
Cardiac testing
Cardiac revascularization
Cardiac revascularization
Implementation / Adherence
Implementation / Adherence
Cardiac testing
Implementation / Adherence
Implementation / Adherence
Implementation / Adherence

Results

Categorical


Hospitalization (Discharge rate (not hospitalized))

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)
ED visit
Total (N analyzed)
p value
Events
Percentage
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)

Cardiac testing (Stress-ECG)

All Participants after rule-out and direct discharge
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)
30 (d)
Total (N analyzed)
% change
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)

Cardiac testing (Stress-Echo)

All Participants after rule-out and direct discharge
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)
30 (d)
Total (N analyzed)
% change
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)

Cardiac testing (Stress-MRI )

All Participants after rule-out and direct discharge
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)
30 (d)
Total (N analyzed)
% change
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)

Cardiac testing (Triple rule-out CT )

All Participants after rule-out and direct discharge
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)
30 (d)
Total (N analyzed)
% change
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)

Cardiac testing (MRI)

All Participants after rule-out and direct discharge
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)
30 (d)
Total (N analyzed)
% change
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)

Cardiac testing (TTE/TEE (transthoracic echocardiography; transesophageal echocardiography))

All Participants after rule-out and direct discharge
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)
30 (d)
Total (N analyzed)
% change
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)

Death, all-cause (Mortality at 30 days )

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)
30 (d)
Total (N analyzed)
% change
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)

Cardiac testing (Coronary angiography )

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)
30 (d)
Total (N analyzed)
% change
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)

Cardiac revascularization (PCI: Coronary angiography with PCI)

Among those who underwent coronary angiography
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)
30 (d)
Total (N analyzed)
% change
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)

Cardiac revascularization (PCI: Coronary angiography without PCI)

Among those who underwent coronary angiography
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)
30 (d)
Total (N analyzed)
% change
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)

Implementation / Adherence (Pre-post change in 0/1 Algorithm)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (Post-implemen...)
vs.
not hs-cTn (Pre-implement...)
ED visit
Total (N analyzed)
% change
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (Post-implemen...)
vs.
not hs-cTn (Pre-implement...)

Implementation / Adherence (Pre-post change 0/3 Algorithm)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
All Arms (ANOVA)
ED visit
Total (N analyzed)
% change
Events
p value
Percentage
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
All Arms (ANOVA)

Cardiac testing (Coronary angiography within 30 days)

Among those who underwent coronary angiography
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)
< 6 (h)
Total (N analyzed)
p value
Events
Percentage
< 72 (h)
Total (N analyzed)
p value
Events
Percentage
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)

Implementation / Adherence (Rule-out rate by implementation)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)
ED visit
Total (N analyzed)
p value
Events
Percentage
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)

Implementation / Adherence (Rule-in rate by implementation)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)
ED visit
Total (N analyzed)
p value
Events
Percentage
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)

Implementation / Adherence (Observational zone rate by implementation)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)
ED visit
Total (N analyzed)
p value
Events
Percentage
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
not hs-cTn (Pre-implement...)
vs.
hs-cTn (Post-implemen...)

Continuous


ED Visit duration (Length of Stay (hours))

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
vs.
ED visit (h)
Total (N analyzed)
p value (Median Difference)
Median
25th percentile
75th percentile
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
vs.

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