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-cTnOBSSES Protocol: hs-cTnT at T0 (between 2-4 h after the onset of symptoms), T2( 2h after T0) and T4 (> 4h of the onset of symptoms) + TIMI score + serial ECG + exercise treadmill test (ETT) within 1week

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
CategoricalHospitalizationDiagnosed as ACS and admitted (High risk)
  • All Participants
  • ED visit
CategoricalHospitalizationDischarged not admitted (Low risk)
  • All Participants
  • ED visit
CategoricalCardiac testingExercise treadmill test (ETT) among discharged patients
  • Among discharged patients
  • 1 (wk)
CategoricalCardiac testing Invasive coronary angiogram
  • Among discharged and with positive or inconclusive ETT
  • 30 (d)
CategoricalCardiac testingDefault the Exercise treadmill test, ETT, and excluded from the study (of all excluded)
  • Among patients excluded from the study
  • ED visit
CategoricalMACE
  • Low-risk patients with ETT negative
  • Among discharged patients
  • Among high-risk admitted patients
  • Among low risk admitted patients
  • Among high-risk discharge patients
  • Among low risk defaulted ETT/Clinic
  • Among low risk discharged without further follow-up
  • 30 (d)
CategoricalMACEUnstable angina
  • Among admitted patients treated as ACS
  • 30 (d)
CategoricalMACEUnstable angina, Among excluded patients ( 154 patients were excluded from the study because 94 did not follow OBSSES Protocol, 45 defaulted ETT, and 15 defaulted physician clinic follow-up)
  • Patients met the criteria for admission but discharged
  • Patients met the criteria for discharge with ETT but admitted
  • 30 (d)
CategoricalMI, anyNSTEMI, Among excluded patients ( 154 patients were excluded from the study because 94 did not follow OBSSES Protocol, 45 defaulted ETT, and 15 defaulted physician clinic follow-up
  • Patients met the criteria for admission but discharged
  • 30 (d)
CategoricalMI, any NSTEMI: Non-ST elevation myocardial infarction
  • Among admitted patients treated as ACS
  • Hospitalization
CategoricalDeath, cardiac
  • Among admitted patients treated as ACS
  • Hospitalization
CategoricalCardiac revascularizationPCI among patients with positive exercise treadmill test
  • Among patients with positive exercise treadmill test
  • 30 (d)
CategoricalReturn to ED or hospitalED revisit, Among excluded patients ( About 154 patients were excluded from the study because 94 did not follow OBSSES Protocol, 45 defaulted ETT, and 15 defaulted physician clinic follow-up)
  • Patients supposed to be discharged with ETT but were discharged without further follow-up
  • Patients defaulted ETT
  • 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
Cardiac testing
Universal
Other
Other reference
Cardiac testing
Universal
Other
Other reference
Cardiac testing
Universal
Other
Other reference
MACE
Universal
Other
Other reference
MACE
Universal
Other
Other reference
MACE
Universal
Other
Other reference
MI, any
Universal
Other
Other reference
MI, any
Universal
Other
Other reference
Death, cardiac
Universal
Other
Other reference
Cardiac revascularization
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
Hospitalization
Hospitalization
Cardiac testing
Cardiac testing
Cardiac testing
MACE
MACE
MACE
MI, any
MI, any
Death, cardiac
Cardiac revascularization
Return to ED or hospital

Results

Categorical


Hospitalization (Diagnosed as ACS and admitted (High risk))

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)
Note
p value
Within Arm ComparisonsNet Comparisons
hs-cTn

Hospitalization (Discharged not admitted (Low risk))

All Participants
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
ED visit
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
Note
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn

Cardiac testing (Exercise treadmill test (ETT) among discharged patients)

Among discharged patients
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
1 (wk)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
Note
p value
Within Arm ComparisonsNet Comparisons
hs-cTn

Cardiac testing ( Invasive coronary angiogram)

Among discharged and with positive or inconclusive ETT
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
Note
p value
Within Arm ComparisonsNet Comparisons
hs-cTn

Cardiac testing (Default the Exercise treadmill test, ETT, and excluded from the study (of all excluded))

Among patients excluded from the study
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
ED visit
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
Note
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn

MACE

Low-risk patients with ETT negative
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
Note
p value
Within Arm ComparisonsNet Comparisons
hs-cTn
Among discharged patients
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
Note
p value
Within Arm ComparisonsNet Comparisons
hs-cTn
Among high-risk admitted patients
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
Note
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn
Among low risk admitted patients
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
Note
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn
Among high-risk discharge patients
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
Note
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn
Among low risk defaulted ETT/Clinic
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
Note
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn
Among low risk discharged without further follow-up
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
Note
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn

MACE (Unstable angina)

Among admitted patients treated as ACS
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
Note
p value
Within Arm ComparisonsNet Comparisons
hs-cTn

MACE (Unstable angina, Among excluded patients ( 154 patients were excluded from the study because 94 did not follow OBSSES Protocol, 45 defaulted ETT, and 15 defaulted physician clinic follow-up))

Patients met the criteria for admission but discharged
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
Note
p value
Within Arm ComparisonsNet Comparisons
hs-cTn
Patients met the criteria for discharge with ETT but admitted
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
Note
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
hs-cTn

MI, any (NSTEMI, Among excluded patients ( 154 patients were excluded from the study because 94 did not follow OBSSES Protocol, 45 defaulted ETT, and 15 defaulted physician clinic follow-up)

Patients met the criteria for admission but discharged
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
Note
p value
Within Arm ComparisonsNet Comparisons
hs-cTn

MI, any ( NSTEMI: Non-ST elevation myocardial infarction)

Among admitted patients treated as ACS
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
Hospitalization
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
Note
p value
Within Arm ComparisonsNet Comparisons
hs-cTn

Death, cardiac

Among admitted patients treated as ACS
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
Hospitalization
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
Note
p value
Within Arm ComparisonsNet Comparisons
hs-cTn

Cardiac revascularization (PCI among patients with positive exercise treadmill test)

Among patients with positive exercise treadmill test
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
Note
p value
Within Arm ComparisonsNet Comparisons
hs-cTn

Return to ED or hospital (ED revisit, Among excluded patients ( About 154 patients were excluded from the study because 94 did not follow OBSSES Protocol, 45 defaulted ETT, and 15 defaulted physician clinic follow-up))

Patients supposed to be discharged with ETT but were discharged without further follow-up
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
Note
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
hs-cTn
Patients defaulted ETT
Descriptive StatisticsBetween Arm Comparisons
hs-cTn
30 (d)
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
Note
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