|
STUDY REVIEW
|
Is / Are
identified
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Is / Are
justified
|
Add(s) value
|
|
INTRODUCTION
|
|
|
|
|
Clinical or methodological context
|
+ 0
-
|
+ 0
-
|
+ 0
-
|
|
Positioning with respect to
literature
|
+ 0
-
|
+ 0
-
|
+ 0
-
|
|
Study objectives
|
+ 0
-
|
+ 0
-
|
+ 0
-
|
|
Study hypotheses
|
+ 0
-
|
+ 0
-
|
+ 0 -
|
|
METHODS
|
|
|
|
|
Study
population
|
|
|
|
|
Study type
(retrospective or prospective)
|
+ 0
-
|
+ 0
-
|
|
|
Data collection
setting(s) and location(s)
|
+ 0
-
|
+ 0
-
|
|
|
Information on
participant recruitment, sampling, and allocation
|
+ 0
-
|
+ 0
-
|
|
|
Inclusion and
exclusion criteria for the study population
|
+ 0
-
|
+ 0
-
|
|
|
Clinical and
demographic characteristics
|
+ 0
-
|
+ 0
-
|
|
|
Flow of participants through each
stage
|
+ 0
-
|
+ 0
-
|
|
|
Final group numbers for
analysis
|
+ 0
-
|
+ 0 -
|
|
|
Reference standard
|
+ 0
-
|
+ 0
-
|
|
|
Clinical assumptions on
participants and data sets
|
+ 0
-
|
+ 0
-
|
|
|
Medical
imaging data
|
|
|
|
|
Sequence and image parameters
|
+ 0
-
|
+ 0
-
|
|
|
Scanner type, make, manufacturer
|
+ 0
-
|
+ 0
-
|
|
|
Sources of imaging and data noise
|
+ 0
-
|
+ 0
-
|
|
|
Other materials and devices
|
+ 0
-
|
+ 0
-
|
|
|
Methods
|
|
|
|
|
Input parameters to the method
|
+ 0
-
|
+ 0
-
|
|
|
Units, cutoffs,
parameters
|
+ 0
-
|
+ 0
-
|
|
|
Formulas and algorithms
|
+ 0
-
|
+ 0 -
|
+ 0
-
|
|
Implemented hardware and software
|
+ 0
-
|
+ 0
-
|
+ 0
-
|
|
Number, training
and expertise of raters
|
+ 0
-
|
+ 0
-
|
+ 0
-
|
|
Outcome measures and methods
|
+ 0
-
|
+ 0
-
|
+ 0
-
|
|
Sample size
|
+ 0
-
|
+ 0
-
|
|
|
Expected result or model,
considering sample size
|
+ 0
-
|
+ 0
-
|
+ 0
-
|
|
Validation criterion
|
+ 0
-
|
+ 0
-
|
+ 0
-
|
|
Validation objective
|
+ 0
-
|
+ 0
-
|
+ 0
-
|
|
Type, number and
characteristics of validation data sets
|
+ 0
-
|
+ 0
-
|
|
|
Sensitivity
analysis to parameters
|
+ 0
-
|
+ 0
-
|
+ 0
-
|
|
Statistical test(s)
|
+ 0
-
|
+ 0
-
|
+ 0
-
|
|
RESULTS
|
|
|
|
|
Participants
inclusion/exclusions
|
+ 0
-
|
+ 0
-
|
+ 0
-
|
|
Result of statistical test(s)
|
+ 0
-
|
+ 0
-
|
+ 0
-
|
|
Cross tabulation of test
results by reference results
|
+ 0
-
|
+ 0
-
|
+ 0
-
|
|
Estimates of
accuracy and measures of statistical uncertainty
|
+ 0
-
|
+ 0
-
|
+ 0
-
|
|
Measures of test
reproducibility, if done
|
+ 0
-
|
+ 0
-
|
+ 0
-
|
|
Ancillary analyses
|
+ 0
-
|
+ 0
-
|
+ 0
-
|
|
DISCUSSION
|
|
|
|
|
Claims
|
|
|
|
|
Clinical realism
|
+ 0
-
|
+ 0
-
|
+ 0
-
|
|
Claims supported by data
|
+ 0
-
|
+ 0
-
|
+ 0
-
|
|
Possible or actual bias,
discrepancies
|
+ 0
-
|
+ 0
-
|
|
|
Interpretation of results given
hypotheses and sources of bias
|
+ 0
-
|
+ 0
-
|
+ 0
-
|
|
Generalization of findings
|
+ 0
-
|
+ 0
-
|
+ 0
-
|
|
Innovation
and impact
|
|
|
|
|
Original concepts, new technology
usage
|
+ 0
-
|
+ 0
-
|
+ 0
-
|
|
Innovation: transformational,
translational, incremental
|
+ 0
-
|
+ 0
-
|
+ 0
-
|
|
Scientific and/or
practical value of findings and results
|
+ 0
-
|
+ 0
-
|
+ 0
-
|
|
Clinical
applicability
|
+ 0
-
|
+ 0
-
|
+ 0
-
|
|
Ethics
|
|
|
|
|
Social, safety, ethical or economic
issues
|
+ 0
-
|
+ 0
-
|
+ 0
-
|
|
Ethics committee
approval and informed consent for subjects
|
+ 0
-
|
+ 0
-
|
|
|
Human study - in accordance with the
Declaration of Helsinki
|
+ 0
-
|
+ 0
-
|
|
|
Animal study - in accordance with the
Guiding Principles
|
+ 0
-
|
+ 0
-
|
|
|
Sources of funding
and role of study sponsor(s)
|
+ 0
-
|
|
|
|
Authors'
contributions, medical writer or editor involvement
|
+ 0
-
|
|
|
|
Potential conflicts
of interest
|
+ 0
-
|
|
|