AI study - Accelerating availability of clinically-relevant parameter estimates from Thromboelastogram point-
of-care device
Domain Key items
SOURCE OF DATA Source of data (e.g., cohort, case-control,
randomized trial participants, or registry data)
Participant eligibility and recruitment method (e.g.,
consecutive participants, location, number of
centers, setting, inclusion and exclusion criteria)
PARTICIPANTS
Participant description
Details of treatments received, if relevant
Study dates
OUTCOME(S) TO
BE PREDICTED
Definition and method for measurement of outcome
Was the same outcome definition (and method for
measurement) used in all patients?
Type of outcome (e.g., single or combined
endpoints)
Was the outcome assessed without knowledge of
the candidate predictors (i.e., blinded)?
Info
RCTs
Design of the Study of Tranexamic Acid during Air Medical
Prehospital Transport (STAAMP) Trial – Level I trauma
centres, trauma patients with hypotension and
tachycardia, USA.
Taking the Blood Bank to the Field: The Design and
Rationale of the Prehospital Air Medical Plasma (PAMPer)
Trial.
Trauma patients
Tranexamic acid, prehospital plasma transfusion
Trials used - PAMPer 2016. STAAMP 2014
1. Dynamic Model Construction:
 Dynamic model was built using
thromboelastogram (TEG) data.
 Patient-specific parameters include initial
platelet count (P(0)), platelet activation rate
(k1), thrombus growth rate (k2), and lysis
rate (k3).
2. Data Collection:
 Patient data from STAAMP and PAMPer
clinical trials were gathered.
 873 RapidTEGs were analyzed, with 116
indicating maximum amplitude (MA) below
normal and 466 indicating lysis percent
above normal.
3. Virtual Library Creation:
 A virtual library of over 160,000 simulated
RapidTEGs was generated using the dynamic
model.
4. Comparison and Trajectory Analysis:
 Patient TEG responses were compared
against the virtual library to identify
trajectories with the least sum-of-squared
error up to specified evaluation times.
 Logistic regression was performed using 10
nearest-neighbor trajectories to predict
specific TEG outcomes.
 Were candidate predictors part of the outcome (e.g.,
in panel
Time or consensus
of outcome diagnosis)?
occurrence or summary of duration
of follow-up
Number and type of predictors (e.g., demographics,
patient history, physical examination, additional
testing, disease
Definition characteristics)
and method for measurement of
CANDIDATE
PREDICTORS candidate
Timing predictorsmeasurement (e.g., at patient
of predictor
(OR INDEX TESTS) presentation,
Were predictorsat diagnosis, at treatment
assessed blinded initiation)
for outcome, and
for each other (if relevant)?
Handling of predictors in the modelling (e.g.,
continuous, linear, non-linear transformations or
categorised)
Number of participants and number of
SAMPLE SIZE outcomes/events
Number of outcomes/events in relation to the
number
Number of
of candidate predictors
participants with any(Events
missingPer Variable)
value
MISSING DATA (include predictors
Number and outcomes)
of participants with missing data for each
predictor
Handling of missing data (e.g., complete-case
analysis,
Modellingimputation, or other
method (e.g., methods)
logistic, survival, neural
network, orassumptions
Modelling machine learning techniques)
satisfied
Method for selection of predictors for inclusion in
MODEL multivariable modelling (e.g., all candidate
DEVELOPMENT predictors,
Method forpre-selection based on unadjusted
selection of predictors during
multivariable modelling (e.g., full model approach,
backward
Shrinkage or forward selection)
of predictor and
weights or criteria used
regression
coefficients (e.g., no shrinkage, uniform shrinkage,
penalized
Calibrationestimation)
(calibration plot, calibration slope,
MODEL Hosmer-Lemeshow test) and Discrimination
PERFORMANCE (C-statistic,
ClassificationD-statistic,
measureslog-rank) measures
(e.g., sensitivity, with
specificity,
predictive values, net reclassification improvement)
and whether
Method useda-priori cut model
for testing points performance:
were used
development dataset only (random split of data,
MODEL resampling methods e.g. bootstrap or cross-
EVALUATION validation, none) or separate external validation (e.g.
In case of poor validation, whether model was
adjusted or updated (e.g., intercept recalibrated,
predictor effectsmultivariable
Final and other adjusted, or new predictors
models added)
(e.g., basic,
extended, simplified) presented, including predictor
weights or regression coefficients, intercept,
baseline survival, model performance measures
RESULTS Any alternative presentation of the final prediction
models, e.g., sum score, nomogram, score chart,
predictions
Comparisonfor specific
of the risk subgroups
distribution with
of predictors
(including missing data) for development and
validation datasets
Interpretation of presented models (confirmatory,
INTERPRETATION i.e., model useful for practice versus exploratory, i.e.,
AND DISCUSSION more research needed)
Comparison with other studies, discussion of
generalizability, strengths and limitations.