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
hs-cTnLocal standard: ESC 0/1h algorithm + history + physical exam + ECG + CXR

Arm Details

1. hs-cTn info
Click NR checkboxes in each row with no reported data
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 durationUntil (hospitalization, discharge or need for more studies)
  • All Participants
  • ED visit (min)
CategoricalHospitalizationAdmission among the patients evaluated in ED
  • All Participants
  • OBSERVE group
  • RULE-IN group
  • ROLE-OUT group
  • ED visit
CategoricalDeath, cardiovascularCardiovascular mortality
  • All Participants
  • RULE-OUT group
  • OBSERVE group
  • RULE-IN group
  • 30 (d)
CategoricalMACE
  • All Participants
  • RULE-OUT group
  • OBSERVE group
  • RULE-IN group
  • Rule out - Present less than 4 hours from onset
  • Rule in - Present less than 4 hours from onset
  • Observe - Present less than 4 hours from onset
  • NOte: compare MACE between rule out observe and rule in
  • 30 (d)
CategoricalMI, anyAcute MI (AMI)
  • All Participants
  • RULE-OUT group
  • OBSERVE group
  • RULE-IN group
  • Rule out - Present less than 4 hours from onset
  • Rule in - Present less than 4 hours from onset
  • Observe - Present less than 4 hours from onsetRule in - Present less than 4 hours from onset
  • 30 (d)
CategoricalCardiac revascularizationPCI
  • All Participants
  • 30 (d)
CategoricalCardiac revascularization CABG (Coronary artery bypass grafting)
  • 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
Hospitalization
Universal
Other
Other reference
Death, cardiovascular
Universal
Other
Other reference
MACE
Universal
Other
Other reference
MI, any
Universal
Other
Other reference
Cardiac revascularization
Universal
Other
Other reference
Cardiac revascularization
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
Death, cardiovascular
MACE
MI, any
Cardiac revascularization
Cardiac revascularization

Results

Categorical


Hospitalization (Admission among the patients evaluated in ED)

All Participants
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
ED visit
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn
OBSERVE group
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
ED visit
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn
RULE-IN group
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
ED visit
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn
ROLE-OUT group
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
ED visit
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn

Death, cardiovascular (Cardiovascular mortality)

All Participants
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn
RULE-OUT group
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn
OBSERVE group
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn
RULE-IN group
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn

MACE

All Participants
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn
RULE-OUT group
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn
OBSERVE group
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn
RULE-IN group
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn
Rule out - Present less than 4 hours from onset
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn
Rule in - Present less than 4 hours from onset
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn
Observe - Present less than 4 hours from onset
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn
NOte: compare MACE between rule out observe and rule in
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn

MI, any (Acute MI (AMI))

All Participants
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn
RULE-OUT group
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn
OBSERVE group
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn
RULE-IN group
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn
Rule out - Present less than 4 hours from onset
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn
Rule in - Present less than 4 hours from onset
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn
Observe - Present less than 4 hours from onsetRule in - Present less than 4 hours from onset
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn

Cardiac revascularization (PCI)

All Participants
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn

Cardiac revascularization (CABG (Coronary artery bypass grafting))

All Participants
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn

Continuous


ED Visit duration (Until (hospitalization, discharge or need for more studies))

All Participants
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
ED visit (min)
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
hs-cTn

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