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-cTnADAPT-ADP: Standard-care ADP (cardiac chest pain pathway): Initial ECG + Hs-cTnI at 0, 2h + modified TIMI
hs-cTnEDACS-ADP: Experimental ADP: Initial ECG + Hs-cTnI at 0, 2h + EDACS 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
CategoricalED Visit durationDischarged within 6 h (Negative index test result (negative ECG result, negative 0- and 2-h troponin result) and no MACE event within 30 days of presentation, and medical decision to discharge home made within 6 hours of ED presentation)
  • All Participants
  • ED visit
CategoricalED Visit durationStay < 6h, low risk a discharged within 6 h (Negative index test result (negative ECG result, negative 0- and 2-h troponin result, score <threshold, no red flags) and no MACE event within 30 days of presentation, and medical decision to discharge home made within 6 hours of ED presentation).
  • All Participants
  • ED visit
CategoricalDeath, all-causeDiagnoses during initial presentation (all in non-low-risk patients)
  • All Participants
  • During initial presentation
CategoricalCardiac revascularizationEmergency revascularization. Diagnoses during initial presentation (all in non-low risk patients)
  • All Participants
  • During initial presentation
CategoricalMI, anyNSTEMI During initial presentation (all in non-low-risk patients)
  • All Participants
  • During initial presentation
CategoricalMI, anyNSTEMI, during readmissions during 30 days after index presentation (all in non–low-risk patients)
  • All Participants
  • Low risk patients
  • 30 (d)
CategoricalMI, anySTEMI, during initial presentation in which patients with initial STEMI were excluded (all in non low risk patients)
  • All Participants
  • During initial presentation
CategoricalMI, anySTEMI, during readmission during 30 days after index presentation (all in non–low-risk patients)
  • All Participants
  • Low risk patients
  • 30 (d)
CategoricalMACETotal patients with a MACE. Diagnoses during initial presentation (STEMI + NSTEMI)
  • All Participants
  • During initial presentation
CategoricalMACEUnstable angina in non-low-risk patients (This outcome placed under MACE based on the review protocol)
  • All Participants
  • During initial presentation
CategoricalMACEMACE within 30 days of presentation (from index presentation or readmission)
  • All Participants
  • Low risk patients
  • 30 (d)
CategoricalMACEMACE (STEMI + NSTEMI) during readmission readmissions during 30 days after index presentation (all in non-low-risk patients)
  • All Participants
  • Low risk patients
  • 30 (d)
CategoricalMACEACS diagnosis during initial presentation (STEMI, NSTEMI, Unstable angina) (All in non low risk patients)
  • All Participants
  • 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
ED Visit duration
Universal
Other
Other reference
Death, all-cause
Universal
Other
Other reference
Cardiac revascularization
Universal
Other
Other reference
MI, any
Universal
Other
Other reference
MI, any
Universal
Other
Other reference
MI, any
Universal
Other
Other reference
MI, any
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
2. MACE components
If a checked component has an asterisk (*), confirm with team before extracting the MACE outcome
ED Visit duration
ED Visit duration
Death, all-cause
Cardiac revascularization
MI, any
MI, any
MI, any
MI, any
MACE
MACE
MACE
MACE
MACE

Results

Categorical


ED Visit duration (Discharged within 6 h (Negative index test result (negative ECG result, negative 0- and 2-h troponin result) and no MACE event within 30 days of presentation, and medical decision to discharge home made within 6 hours of ED presentation))

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (EDACS-ADP:...)
vs.
not hs-cTn (ADAPT-ADP:...)
ED visit
Total (N analyzed)
z
Events
Risk Difference (RD)
Percentage
95% CI low (RD)
95% CI high (RD)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (EDACS-ADP:...)
vs.
not hs-cTn (ADAPT-ADP:...)

ED Visit duration (Stay < 6h, low risk a discharged within 6 h (Negative index test result (negative ECG result, negative 0- and 2-h troponin result, score <threshold, no red flags) and no MACE event within 30 days of presentation, and medical decision to discharge home made within 6 hours of ED presentation).)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (EDACS-ADP:...)
vs.
not hs-cTn (ADAPT-ADP:...)
ED visit
Total (N analyzed)
z
Events
Risk Difference (RD)
Percentage
95% CI low (RD)
95% CI high (RD)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (EDACS-ADP:...)
vs.
not hs-cTn (ADAPT-ADP:...)

Death, all-cause (Diagnoses during initial presentation (all in non-low-risk patients))

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (EDACS-ADP:...)
vs.
not hs-cTn (ADAPT-ADP:...)
During initial presentation
Total (N analyzed)
z
Events
Risk Difference (RD)
Percentage
95% CI low (RD)
95% CI high (RD)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (EDACS-ADP:...)
vs.
not hs-cTn (ADAPT-ADP:...)

Cardiac revascularization (Emergency revascularization. Diagnoses during initial presentation (all in non-low risk patients))

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (EDACS-ADP:...)
vs.
not hs-cTn (ADAPT-ADP:...)
During initial presentation
Total (N analyzed)
z
Events
Risk Difference (RD)
Percentage
95% CI low (RD)
95% CI high (RD)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (EDACS-ADP:...)
vs.
not hs-cTn (ADAPT-ADP:...)

MI, any (NSTEMI During initial presentation (all in non-low-risk patients))

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (EDACS-ADP:...)
vs.
not hs-cTn (ADAPT-ADP:...)
During initial presentation
Total (N analyzed)
z
Events
Risk Difference (RD)
Percentage
95% CI low (RD)
95% CI high (RD)
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (EDACS-ADP:...)
vs.
not hs-cTn (ADAPT-ADP:...)

MI, any (NSTEMI, during readmissions during 30 days after index presentation (all in non–low-risk patients))

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (EDACS-ADP:...)
vs.
not hs-cTn (ADAPT-ADP:...)
30 (d)
Total (N analyzed)
Risk Difference (RD)
Events
95% CI low (RD)
Percentage
95% CI high (RD)
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (EDACS-ADP:...)
vs.
not hs-cTn (ADAPT-ADP:...)
Low risk patients
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)
Risk Difference (RD)
95% CI low (RD)
95% CI high (RD)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn

MI, any (STEMI, during initial presentation in which patients with initial STEMI were excluded (all in non low risk patients) )

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (EDACS-ADP:...)
vs.
not hs-cTn (ADAPT-ADP:...)
During initial presentation
Total (N analyzed)
z
Events
Risk Difference (RD)
Percentage
95% CI low (RD)
95% CI high (RD)
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (EDACS-ADP:...)
vs.
not hs-cTn (ADAPT-ADP:...)

MI, any (STEMI, during readmission during 30 days after index presentation (all in non–low-risk patients))

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (EDACS-ADP:...)
vs.
not hs-cTn (ADAPT-ADP:...)
30 (d)
Total (N analyzed)
Risk Difference (RD)
Events
95% CI low (RD)
Percentage
95% CI high (RD)
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (EDACS-ADP:...)
vs.
not hs-cTn (ADAPT-ADP:...)
Low risk patients
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)
Risk Difference (RD)
95% CI low (RD)
95% CI high (RD)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn

MACE (Total patients with a MACE. Diagnoses during initial presentation (STEMI + NSTEMI))

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (EDACS-ADP:...)
vs.
not hs-cTn (ADAPT-ADP:...)
During initial presentation
Total (N analyzed)
Risk Difference (RD)
Events
95% CI low (RD)
Percentage
95% CI high (RD)
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (EDACS-ADP:...)
vs.
not hs-cTn (ADAPT-ADP:...)

MACE (Unstable angina in non-low-risk patients (This outcome placed under MACE based on the review protocol))

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (EDACS-ADP:...)
vs.
not hs-cTn (ADAPT-ADP:...)
During initial presentation
Total (N analyzed)
Risk Difference (RD)
Events
95% CI low (RD)
Percentage
95% CI high (RD)
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (EDACS-ADP:...)
vs.
not hs-cTn (ADAPT-ADP:...)

MACE (MACE within 30 days of presentation (from index presentation or readmission))

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (EDACS-ADP:...)
vs.
not hs-cTn (ADAPT-ADP:...)
30 (d)
Total (N analyzed)
Risk Difference (RD)
Events
95% CI low (RD)
Percentage
95% CI high (RD)
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (EDACS-ADP:...)
vs.
not hs-cTn (ADAPT-ADP:...)
Low risk patients
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
30 (d)
Total (N analyzed)
Difference
Events
95% CI low
Percentage
95% CI high
p value (difference)
z
p value (MD)
Risk Difference (RD)
95% CI low (RD)
95% CI high (RD)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn

MACE (MACE (STEMI + NSTEMI) during readmission readmissions during 30 days after index presentation (all in non-low-risk patients))

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
All Arms (ANOVA)
30 (d)
Total (N analyzed)
Risk Difference (RD)
Events
95% CI low (RD)
Percentage
95% CI high (RD)
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
All Arms (ANOVA)
Low risk patients
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)
Risk Difference (RD)
95% CI low (RD)
95% CI high (RD)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn

MACE (ACS diagnosis during initial presentation (STEMI, NSTEMI, Unstable angina) (All in non low risk patients))

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn (EDACS-ADP:...)
vs.
not hs-cTn (ADAPT-ADP:...)
30 (d)
Total (N analyzed)
Risk Difference (RD)
Events
95% CI low (RD)
Percentage
95% CI high (RD)
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn (EDACS-ADP:...)
vs.
not hs-cTn (ADAPT-ADP:...)

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