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
Single Choice
RCT
Pre-post (with prospective ADP)
Prospective comparison of interventions (parallel)
Prospective single group
Other
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
Single Choice
Industry
Non-industry
Both industry and non-industry
NR
7. Country/ies
NR should rarely if ever be selected
Multiple Choice
US
Europe (multiple countries)
Australia
Canada
China
France
Germany
Israel
Italy
Japan
Netherlands
Spain
UK
Other
NR
8. Setting
Multiple Choice
ED, tertiary hospital
ED, community hospital
ED, various hospital types
ED, unclear hospital type
Ambulance/EMT/Pre-ED setting
Other
Unclear
Chest pain/OBS unit
9. Centers
If Unclear, add a note why
Single Choice
Single ED (single center)
Multiple EDs (single hospital system)
Multiple centers (multiple hospital systems)
Unclear
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
Multiple Choice
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
Multiple Choice
Gender: Male only
Gender: Female only
Age: Elderly only
Age: Exclude elderly
Age: Other
ACS subgroup
Comorbidity: Diabetes
Comorbidity: Obesity
Comorbidity: Other
CV: Prior CV event (only)
CV: No prior CV event (only)
Other
13. Comments/Notes

Arm Details

1. hs-cTn info
Click NR checkboxes in each row with no reported data
hs-cTn:
DataNR
Test name
Multiple Choice
NR
Manufacturer
Multiple Choice
NR
Generation
Multiple Choice
NR
Limit of detection (ng/L)
Multiple Choice
NR
Comment/Note
Single Choice

99th %ile
Multiple Choice
NR

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
Single Choice
NR
5. Are there significant differences (statistical or clinical) between the two groups?
Single Choice
Yes
No/NR/Unclear
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

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.
Death, all-cause:
Universal
Single Choice
Fourth (4th) Universal Definition (2018)
Third (3rd) Universal Definition (2012)
Second (2nd) Universal Definition (2007)
First (Redefinition) Universal Definition (2000)
Other
Other
Other reference
2. MACE components
If a checked component has an asterisk (*), confirm with team before extracting the MACE outcome
Death, all-cause:
Multiple Choice
Death, all-cause
Death, cardiovascular
Death, cardiac
Death, cerebrovascular
MI
Cardiac/coronary revascularization
Unstable angina
Heart failure*
Stroke
Transient ischemic attack*
Arrhythmia, ventricular
Arrhythmia, any*
Atrial fibrillation*
Peripheral vascular disease*
Other*

Study Risk of Bias

1. Design
Single Choice
RCT (between ADP and other protocol)
Nonrandomized comparison of interventions (between ADP and other protocol)
Single group (all had ADP)
2. Clarity: Discrepancies
Was the article free of discrepancies (eg, between text and tables)? Add note if No (High concern)
Single Choice
Yes (Low concern)
No (High concern)
3. Clarity: Population
Were patient eligibility criteria sufficiently clear? Add note if No (High concern).
Single Choice
Yes (Low concern)
No (High concern)
4. Clarity: Intervention/Comparator
Were the ADP (and comparator) sufficiently clear? Add note if No (High concern)
Single Choice
Yes (Low concern)
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).
Single Choice
Yes (Low concern)
No (High concern)
6. Clarity: Setting
Was the setting sufficiently clearly defined? (Eg, Do we know the hospital (and ED) type?) Add note if No (High concern).
Single Choice
Yes (Low concern)
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
Single Choice
No (low RoB)
Yes (high RoB)
8. Outcome ascertainment
Single Choice
No (or inadequate) description of how final determination of MI was diagnosed [Unclear RoB]
Independent or blind adjudication of MI for each patient by reference to secure medical records [Low RoB]
Record linkage (eg identified through ICD codes on database records) [Moderate RoB]
Self report (by patient or family) with no reference to original structured injury data or imaging [High RoB]
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.
Dependency
  • Question Position: 1
    • - Option: RCT (between ADP and other protocol)
    Single Choice
    No (low RoB)
    Yes (high RoB)
    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)
    Dependency
  • Question Position: 1
    • - Option: Nonrandomized comparison of interventions (between ADP and other protocol)
    • - Option: Single group (all had ADP)
    Single Choice
    Yes (low RoB)
    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)
    Dependency
  • Question Position: 1
    • - Option: Nonrandomized comparison of interventions (between ADP and other protocol)
    Single Choice
    Yes (low RoB)
    No (high RoB)
    12. NRCI: Adjustment for confounders
    Dependency
  • Question Position: 1
    • - Option: Nonrandomized comparison of interventions (between ADP and other protocol)
    Single Choice
    Crude analysis (unadjusted comparison between ADP and no ADP) [High RoB]
    Regression adjustment or patient-matching (accounting for at least age, sex, and symptom duration OR a risk score) [Low RoB]
    Regression adjustment or patient-matching (not accounting at least one of for age, sex, symptom duration, or risk score) [Moderate RoB]
    Propensity score analysis (or equivalent) [Low RoB]

    Suggested Arms

    NameDescription
    hs-cTn
    not hs-cTn

    Please see downloadable data for more

    Suggested Outcomes

    TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)
    CategoricalCardiac revascularization
    CategoricalCardiac testing
    CategoricalDeath, all-cause
    CategoricalDeath, cardiac
    CategoricalDeath, cardiovascular
    CategoricalDelayed intervention
    CategoricalHospitalization
    CategoricalImplementation / Adherence
    CategoricalMACE
    CategoricalMI, any
    CategoricalMI, missed/delayed
    CategoricalMI, Type 1 (atherothrombotic)
    CategoricalMI, Type 2 (non-atherothrombotic)
    CategoricalReturn to ED or hospital
    ContinuousED Visit duration
    ContinuousHospitalization duration

    Please see downloadable data for more