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-cTnBefore: Point of care cTn or Conventional cTn at 0, 3h + modified HEART score.
hs-cTnAfter: Hs-cTnT at 0, 1h + modified HEART score (a novel not validated cTn velocity approach was used also within the pathway)

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
CategoricalHospitalizationAdmitted
  • All Participants
  • ED visit
CategoricalHospitalizationThe combined proportion of patients who left against medical advice or eloped from the ED before completing evaluation
  • All Participants
  • ED visit
CategoricalHospitalizationPatients transferred
  • All Participants
  • ED visit
CategoricalHospitalizationThe proportion of patients discharged from the ED
  • All Participants
  • ED visit
CategoricalMI, anyAMI within 30 days (Prevalence of AMI in each cohort rather than the incident number of AMIs)
  • All Participants
  • 30 (d)
CategoricalMACEMACE within 30 days (Prevalence of MACE in each cohort, inclusive of AMI which are also separately)
  • All Participants
  • 30 (d)
CategoricalMACEMACE during hospitalization after initial ED visit (All patients who had a MACE during hospitalization had one occur within 30 days of ED visit.)
  • Among those who were admitted
  • Hospitalization
CategoricalMACEMACE within 30 days when discharged after initial ED visit (MACE include the diagnosis of type I AMI, coronary revascularization procedures, ventricular arrhythmia, high degree atrioventricular block requiring intervention, cardiogenic shock requiring mechanical support, cardiac arrest with return of spontaneous circulation, and death
  • Among discharged
  • 30 (d)
CategoricalDeath, all-causeIn-hospital death before 30 days
  • All Participants
  • Before 30 (d)
ContinuousED Visit durationLOS (length of stay) , median (IQR), hours
  • All Participants
  • ED visit (h)
ContinuousED Visit durationThe PtDt (the provider-to-disposition time)
  • All Participants
  • ED visit
CategoricalDeath, all-cause30-day Follow up
  • 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.
Hospitalization
Universal
Other
Other reference
Hospitalization
Universal
Other
Other reference
Hospitalization
Universal
Other
Other reference
Hospitalization
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
Death, all-cause
Universal
Other
Other reference
ED Visit duration
Universal
Other
Other reference
ED Visit duration
Universal
Other
Other reference
Death, all-cause
Universal
Other
Other reference
2. MACE components
If a checked component has an asterisk (*), confirm with team before extracting the MACE outcome
Hospitalization
Hospitalization
Hospitalization
Hospitalization
MI, any
MACE
MACE
MACE
Death, all-cause
ED Visit duration
ED Visit duration
Death, all-cause

Results

Categorical


Hospitalization (Admitted)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
ED visit
Total (N analyzed)
Difference
Events
Difference%
Percentage
95% CI low (Difference)
Note
95% CI high (Difference)
Odds Ratio (OR)
95% CI low (OR)
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

Hospitalization (The combined proportion of patients who left against medical advice or eloped from the ED before completing evaluation)

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

Hospitalization (Patients transferred )

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
ED visit
Total (N analyzed)
Difference%
Events
95% CI low (Difference)
Percentage
95% CI high (Difference)
Note
Odds Ratio (OR)
95% CI low (OR)
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

Hospitalization (The proportion of patients discharged from the ED)

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

MI, any (AMI within 30 days (Prevalence of AMI in each cohort rather than the incident number of AMIs))

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
not hs-cTn (Before: Point...)
vs.
hs-cTn (After:...)
30 (d)
Total (N analyzed)
p value
Events
Percentage
Note
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
not hs-cTn (Before: Point...)
vs.
hs-cTn (After:...)

MACE (MACE within 30 days (Prevalence of MACE in each cohort, inclusive of AMI which are also separately))

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
not hs-cTn (Before: Point...)
vs.
hs-cTn (After:...)
30 (d)
Total (N analyzed)
p value
Events
Percentage
Note
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
not hs-cTn (Before: Point...)
vs.
hs-cTn (After:...)

MACE (MACE during hospitalization after initial ED visit (All patients who had a MACE during hospitalization had one occur within 30 days of ED visit.))

Among those who were admitted
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
not hs-cTn (Before: Point...)
vs.
hs-cTn (After:...)
Hospitalization
Total (N analyzed)
p value
Events
Percentage
Note
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
not hs-cTn (Before: Point...)
vs.
hs-cTn (After:...)

MACE (MACE within 30 days when discharged after initial ED visit (MACE include the diagnosis of type I AMI, coronary revascularization procedures, ventricular arrhythmia, high degree atrioventricular block requiring intervention, cardiogenic shock requiring mechanical support, cardiac arrest with return of spontaneous circulation, and death)

Among discharged
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
not hs-cTn (Before: Point...)
vs.
hs-cTn (After:...)
30 (d)
Total (N analyzed)
p value
Events
Percentage
Note
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
not hs-cTn (Before: Point...)
vs.
hs-cTn (After:...)

Death, all-cause (In-hospital death before 30 days)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
Before 30 (d)
Total (N analyzed)
Difference
Events
Difference%
Percentage
95% CI low (Difference)
Note
95% CI high (Difference)
Odds Ratio (OR)
95% CI low (OR)
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

Death, all-cause (30-day Follow up)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
30 (d)
Total (N analyzed)
Difference%
Events
95% CI low (Difference)
Percentage
95% CI high (Difference)
Note
Odds Ratio (OR)
95% CI low (OR)
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

Continuous


ED Visit duration (LOS (length of stay) , median (IQR), hours)

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

ED Visit duration (The PtDt (the provider-to-disposition time))

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
vs.
ED visit
Total (N analyzed)
p value (Median)
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