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-cTnUsual rule-out strategies: Hs-cTn at 0 then at 1 or 3 or 6 h (based on the sites) + Risk tool and definition of low-risk (GRACE or TIMI, or HEART or ECG change or symptoms)
hs-cTn LoDED Strategy: Discharge eligibility: Single hs-cTn at 0h undetectable + ECG (non-ischaemic)

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 durationMedian time to discharge (hours) (IQR)
  • All Participants
  • Patients with an initial hs-cTn below the LoD
  • ED visit
ContinuousHospitalization durationSubsequent nights in hospital
  • All Participants
  • Patients with an initial undetectable hs-cTn
  • end of study
CategoricalED visit durationEarly discharge: Patients successfully discharged within 4 hours (LOS <= 4h)
  • All Participants
  • Patients with an initial hs-cTn below the LoD
  • ED visit
CategoricalCardiac testingAdditional cardiac tests‡ (eg, ECG and exercise tolerance test)
  • Patients with an initial undetectable hs-cTn
  • ED visit
CategoricalImplementation / Adherence Discharged from hospital in accordance with the LoDED strategy
  • Patient with an initial hs-cTn below the LoD
  • ED visit
CategoricalCardiac revascularizationCardiac procedures (heart bypass, stent and pacemaker)
  • All Participants
  • Patients with an initial undetectable hs-cTn
  • 30 (d)
CategoricalMACE
  • All Participants
  • Patients discharged within 4 hours
  • Patients with an initial hs-cTn below the LoD
  • 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 duration
Universal
Other
Other reference
ED visit duration
Universal
Other
Other reference
Cardiac testing
Universal
Other
Other reference
Implementation / Adherence
Universal
Other
Other reference
Cardiac revascularization
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
Hospitalization duration
ED visit duration
Cardiac testing
Implementation / Adherence
Cardiac revascularization
MACE

Results

Categorical


ED visit duration (Early discharge: Patients successfully discharged within 4 hours (LOS <= 4h))

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn ( LoDED...)
vs.
not hs-cTn (Usual...)
ED visit
95%CI Low
Comment
95%CI High
Odds Ratio (OR)
Total (N analyzed)
95% CI low (OR)
Events
95% CI high (OR)
Percentage
Odds Ratio, Adjusted (adjOR)
Note
95% CI low (adjOR)
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn ( LoDED...)
vs.
not hs-cTn (Usual...)
Patients with an initial hs-cTn below the LoD
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
vs.
ED visit
95%CI Low
Comment
95%CI High
Odds Ratio (OR)
Total (N analyzed)
95% CI low (OR)
Events
95% CI high (OR)
Percentage
Odds Ratio, Adjusted (adjOR)
Note
95% CI low (adjOR)
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
vs.

Cardiac testing (Additional cardiac tests‡ (eg, ECG and exercise tolerance test))

Patients with an initial undetectable hs-cTn
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
ED visit
95%CI Low
Comment
95%CI High
Odds Ratio (OR)
Total (N analyzed)
95% CI low (OR)
Events
95% CI high (OR)
Percentage
Odds Ratio, Adjusted (adjOR)
Note
95% CI low (adjOR)
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn

Implementation / Adherence (Discharged from hospital in accordance with the LoDED strategy)

Patient with an initial hs-cTn below the LoD
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
ED visit
95%CI Low
Comment
95%CI High
Odds Ratio (OR)
Total (N analyzed)
95% CI low (OR)
Events
95% CI high (OR)
Percentage
Odds Ratio, Adjusted (adjOR)
Note
95% CI low (adjOR)
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn

Cardiac revascularization (Cardiac procedures (heart bypass, stent and pacemaker) )

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
30 (d)
95%CI Low
Comment
95%CI High
Odds Ratio (OR)
Total (N analyzed)
95% CI low (OR)
Events
95% CI high (OR)
Percentage
Odds Ratio, Adjusted (adjOR)
Note
95% CI low (adjOR)
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
Patients with an initial undetectable hs-cTn
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
30 (d)
95%CI Low
Comment
95%CI High
Odds Ratio (OR)
Total (N analyzed)
95% CI low (OR)
Events
95% CI high (OR)
Percentage
Odds Ratio, Adjusted (adjOR)
Note
95% CI low (adjOR)
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn

MACE

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
hs-cTn ( LoDED...)
vs.
not hs-cTn (Usual...)
30 (d)
95%CI Low
Comment
95%CI High
Odds Ratio (OR)
Total (N analyzed)
95% CI low (OR)
Events
95% CI high (OR)
Percentage
Odds Ratio, Adjusted (adjOR)
Note
95% CI low (adjOR)
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
hs-cTn ( LoDED...)
vs.
not hs-cTn (Usual...)
Patients discharged within 4 hours
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
vs.
30 (d)
95%CI Low
Comment
95%CI High
Odds Ratio (OR)
Total (N analyzed)
95% CI low (OR)
Events
95% CI high (OR)
Percentage
p value
Note
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
vs.
Patients with an initial hs-cTn below the LoD
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
vs.
30 (d)
95%CI Low
Comment
95%CI High
Total (N analyzed)
Events
Percentage
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
vs.

Continuous


ED Visit duration (Median time to discharge (hours) (IQR))

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
ED visit
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
Median
SD (MD)
25th percentile
p value (MD)
75th percentile
Note
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
Patients with an initial hs-cTn below the LoD
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
ED visit
Total (N analyzed)
Mean Difference (MD)
Mean
95% CI low (MD)
SD
95% CI high (MD)
Median
SD (MD)
25th percentile
p value (MD)
75th percentile
Note
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn

Hospitalization duration (Subsequent nights in hospital)

All Participants
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
end of study
Total (N analyzed)
Comment
Mean
Odds Ratio (OR)
SD
95% CI low (OR)
Note
95% CI high (OR)
Odds Ratio, Adjusted (adjOR)
95% CI low (adjOR)
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-cTn
Patients with an initial undetectable hs-cTn
Descriptive StatisticsBetween Arm Comparisons
not hs-cTnhs-cTn
end of study
Total (N analyzed)
Comment
Mean
Odds Ratio (OR)
SD
95% CI low (OR)
95% CI high (OR)
Odds Ratio, Adjusted (adjOR)
95% CI low (adjOR)
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
not hs-cTnhs-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