Extraction form for project: The prognostic value of a baseline platelet count in patients treated with percutaneous coronary intervention: a systematic review and dose-response meta-analysis

Design Details

1. What is the source of data (eg, cohort, RCT, registry data)?
Domain - Source of data. Please, provide the study design
Multiple Choice
Retrospective cohort
Prospective cohort
randomized controlled trial (post-hoc analysis)
registry data
other (please, specify)
2. What was the recruitment method?
Domain - Participants. Please, provide how study population was gathered.
Single Choice
all consecutive patients
random sample
non-random sampling
other (please, specify)
3. The country of recruitment
Domain - Participants. Please, provide the country (countries) of the study.
4. number of centres number of centres
Domain - Participants
5. Settings for study participants
Domain - Participants
Multiple Choice
tertiary
non-tertiary
university hospital
general hospital
military hospital
other
6. Inclusion criteria
Domain - Participants. Please, specify additional inclusion criteria
Single Choice
only STEMI
only NSTEMI
only MI
NST-ACS
only stable CAD
different clinical forms of CAD after PCI
ACS
other
7. Exclusion criteria
Domain - Participants
8. Details of treatments received (if relevant)
Domain - Participant. Please, specify additional details. Choose all relevant options
Multiple Choice
DES
BMS
ticagrelor
clopidogrel
prasugrel
GP2b/3a inhibitors
scaffolds
other
9. Study dates
Domain - Participants

Arm Details

1. Definition and method for measurement of prognostic factors
Domain - Prognostic factors. Please, provide definitions of thrombocytopenia or thrombocytosis if relevant
Baseline platelet values:
Definitions
Multiple Choice
severe thrombocytopenia (PLT value)
moderate thrombocytopenia (PLT value)
mild thrombocytopenia (PLT value)
any thrombocytopenia (PLT value)
normal values of PLT
thrombocytosis (PLT value)
PLT as a continuous variable (specify the unit increase)
other
Blood analyzer used
2. Timing of PLT measurement (eg, at patient presentation, diagnosis, treatment initiation, at the end of PCI)
Domain - Prognostic factor.
Baseline platelet values:
Multiple Choice
baseline PLT (specify the time of measurement)
3. Were prognostic factors assessed blinded for outcome, and for each other (if relevant)?
Domain - Prognostic Factor.
Baseline platelet values:
Single Choice
Yes
No
Unknown
Other
4. Handling of prognostic factors in the analysis (eg, continuous, linear, non-linear transformations or categorised)
Domain - Prognostic factor
Baseline platelet values:
Multiple Choice
continuous
categorised (specify cutpoints)
linear (specify unit)
non-linear transformations (splines, polynomials, or other)

Sample Characteristics

1. Was a sample size calculation conducted?
Domain - Sample size. Sample size calculation might be provided in the protocol published previously.
Baseline platelet values:
Single Choice
Yes (specify how)
No
Unknown
2. What is the number of included participants?
Domain - Sample size
Baseline platelet values:
3. What is the number of patients experienced outcomes?
Domain - Sample size. If several endpoints are reported, please, provide the number of primary endpoints
Baseline platelet values:
MACE
4. Number of outcomes or events in relation to the number of candidate prognostic factors (events per variable)
Domain - Sample size. For the primary endpoint
Baseline platelet values:
5. Number of participants with any missing value (in the prognostic factors and outcomes)
Domain - Missing data. Please, provide data on the number of participants with any missing value in the the prognostic factors?
Baseline platelet values:
Single Choice
Yes, reported (specify the number)
not reported
no missing value
other
6. Details of attrition (loss to follow-up) and, for time-to-event outcomes, number of censored observations (ideally in each category for those categorical prognostic factors of interest)
Domain - Missing data.
Baseline platelet values:
Single Choice
Provided, in general (specify the number)
Provided, for each category of baseline PLT (specify the number)
Not provided
Other
7. Handling of missing data (eg, complete case analysis, imputation, or other methods)
Domain - Missing Data
Baseline platelet values:
Multiple Choice
Not reported
complete case analysis
imputation
other
8. Modelling method (eg, linear, logistic, Cox, parametric survival, competing risks) regression)
Domain - Analysis.
Baseline platelet values:
Multiple Choice
Logistic regression
Cox regression
parametric survival regression
competing risks regression
not provided
other
9. How modelling assumptions were checked; in particular, for time-to-event outcomes and the analysis of hazard ratios, the method for assessing non-proportional hazards (non-constant hazard ratios over time)
Domain - Analysis.
Baseline platelet values:
Single Choice
checked (specify the method)
not checked
unknown
10. Method for selection of prognostic factors for inclusion in multivariable modelling
Domain - Analysis.
Baseline platelet values:
Multiple Choice
all candidate prognostic factors considered
preselection of established prognostic factors,
retain only those significant from univariable analysis
unknown
other
11. Method for selection or exclusion of prognostic factors during multivariable modelling, and criteria used for any selection or exclusion
Domain - Analysis
Baseline platelet values:
Method for selection or exclusion
Multiple Choice
backward selection
forward selection
full model approach
unknown
other
criteria used for any selection
Multiple Choice
P value
Akaike information criterion
Unknown
other
12. Method of handling each continuous prognostic factor
Domain - Analysis.
Baseline platelet values:
Cutpoints
Units for linear variable
13. Number and set of adjustment factors
Domain - Results
Baseline platelet values:
Number
Set
14. Interpretation of presented results
Domain - Interpretation
Baseline platelet values:
Single Choice
provided
not provided
other
15. Comparison with other studies, discussion of generalisability, strengths and limitations
Domain - Interpretation
Baseline platelet values:
Single Choice
provided
not provided
other

Outcome Details

1. Definition and method for measurement of outcomes
Domain - Outcomes. Please, specify the used definitions (international or self-defined) and method for measurement
Baseline platelet values:
Definition
Method for measurement
Multiple Choice
National Registry of death
Electronic Health Records
Medical records
telephone interviews
Clinical visits
Questionnaire
Not reported
Other
2. Was the same outcome definition (and method for measurement) used in all participants?
Domain - Outcomes
Baseline platelet values:
Single Choice
Yes
No
Unknown
Other
3. Types of outcomes (eg, single or combined endpoints)?
Domain - Outcomes.
Baseline platelet values:
Single Choice
Single
combine
other
4. Were the outcomes assessed without knowledge of the candidate prognostic factors (that is, blinded)?
Domain - Outcomes.
Baseline platelet values:
Single Choice
Yes, blinded
No, unblinded
Unknown
Other
5. Were candidate prognostic factors part of the outcome (eg, when using a panel or consensus outcome measurement)?
Domain - Outcomes.
Baseline platelet values:
Single Choice
Yes
No
Other
6. Time of outcome occurrence or summary of duration of follow-up
Domain - Outcomes
Baseline platelet values:

Risk of Bias Assessment

1. 1. Study Participation
Hayden JA, van der Windt DA, Cartwright JL, Côté P, Bombardier C. Assessing bias in studies of prognostic factors. Ann Intern Med. 2013 Feb 19;158(4):280-6.
The source population or population of interest is adequately described for key characteristics (LIST).
Single Choice
Yes
Partial
No
unsure
The sampling frame and recruitment are adequately described, including methods to identify the sample sufficient to limit potential bias (number and type used, e.g., referral patterns in health care)
Single Choice
Yes
Partial
No
Unsure
Period of recruitment is adequately described
Single Choice
Yes
Partial
No
Unsure
Place of recruitment (setting and geographic location) are adequately described
Single Choice
Yes
Partial
No
Unsure
Inclusion and exclusion criteria are adequately described (e.g., including explicit diagnostic criteria or “zero time” description).
Single Choice
Yes
Partial
No
Unsure
There is adequate participation in the study by eligible individuals
Single Choice
Yes
Partial
No
Unsure
The baseline study sample (i.e., individuals entering the study) is adequately described for key characteristics
Single Choice
Yes
Partial
No
Unsure
Summary Study participation
Single Choice
high
moderate
low
2. 2. Study Attrition
Hayden JA, van der Windt DA, Cartwright JL, Côté P, Bombardier C. Assessing bias in studies of prognostic factors. Ann Intern Med. 2013 Feb 19;158(4):280-6.
Response rate (i.e., proportion of study sample completing the study and providing outcome data) is adequate.
Single Choice
Yes
Partial
No
Unsure
Attempts to collect information on participants who dropped out of the study are described.
Single Choice
Yes
Partial
No
Unsure
Reasons for loss to follow-up are provided.
Single Choice
Yes
Partial
No
Unsure
Participants lost to follow-up are adequately described for key characteristics.
Single Choice
Yes
Partial
No
Unsure
There are no important differences between key characteristics (LIST) and outcomes in participants who completed the study and those who did not.
Single Choice
Yes
Partial
No
Unsure
Study Attrition Summary
Single Choice
high
moderate
low
3. 3. Prognostic Factor Measurement
Hayden JA, van der Windt DA, Cartwright JL, Côté P, Bombardier C. Assessing bias in studies of prognostic factors. Ann Intern Med. 2013 Feb 19;158(4):280-6.
A clear definition or description of 'PF' is provided
A clear definition or description of 'PF' is provided
Single Choice
Yes
Partial
No
Unsure
Method of PF measurement is adequately valid and reliable to limit misclassification bias
Single Choice
Yes
Partial
No
Unsure
Appropriate cut-points are used.
Single Choice
Yes
Partial
No
Unsure
measurement of PF is the same for all study participants
Single Choice
Yes
Partial
No
Unsure
Adequate proportion of the study sample has complete data
Single Choice
Yes
Partial
No
Unsure
Appropriate methods of imputation
Single Choice
Yes
Partial
No
Unsure
Summary
Single Choice
high
moderate
low
4. 4. Outcome Measurement
Hayden JA, van der Windt DA, Cartwright JL, Côté P, Bombardier C. Assessing bias in studies of prognostic factors. Ann Intern Med. 2013 Feb 19;158(4):280-6.
A clear definition of outcome is provided
Single Choice
Yes
Partial
No
Unsure
The method of outcome measurement used is adequately valid and reliable to limit misclassification bias
Single Choice
Yes
Partial
No
Unsure
outcome measurement is the same for all study participants.
Single Choice
Yes
Partial
No
Unsure
Summary
Single Choice
high
moderate
low
5. 5. Study Confounding
Hayden JA, van der Windt DA, Cartwright JL, Côté P, Bombardier C. Assessing bias in studies of prognostic factors. Ann Intern Med. 2013 Feb 19;158(4):280-6.
All important confounders are measured.
Single Choice
Yes
Partial
No
Unsure
Clear definitions of the important confounders measured are provided
Single Choice
Yes
Partial
No
Unsure
Valid and Reliable Measurement of Confounders
Single Choice
Yes
Partial
No
Unsure
confounding measurement are the same for all study participants.
Single Choice
Yes
Partial
No
Unsure
Appropriate methods are used for imputation
Single Choice
Yes
Partial
No
Unsure
Important potential confounders are accounted for in the study design
Single Choice
Yes
Partial
No
Unsure
Important potential confounders are accounted for in the analysis
Single Choice
Yes
Partial
No
Unsure
Summary
Single Choice
high
moderate
low
6. 6. Statistical Analysis and Reporting
Hayden JA, van der Windt DA, Cartwright JL, Côté P, Bombardier C. Assessing bias in studies of prognostic factors. Ann Intern Med. 2013 Feb 19;158(4):280-6.
There is sufficient presentation of data to assess the adequacy of the analysis.
Single Choice
Yes
Partial
No
Unsure
The strategy for model building is appropriate
Single Choice
Yes
Partial
No
Unsure
The selected statistical model is adequate
Single Choice
Yes
Partial
No
Unsure
There is no selective reporting of results.
Single Choice
Yes
Partial
No
Unsure
Summary
Single Choice
high
moderate
low

Suggested Arms

NameDescription
Baseline platelet valuesThe study provided data on prognostic value of baseline platelet count.
Total All Arms combined

Please see downloadable data for more

Suggested Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)
CategoricalBaseline platelet valuesAll bleeding
CategoricalBaseline platelet valuesAll stroke
CategoricalBaseline platelet valuesAll-cause mortality
CategoricalBaseline platelet valuesCV mortality
CategoricalBaseline platelet valuesHemorrhagic stroke
CategoricalBaseline platelet valuesIschemic stroke
CategoricalBaseline platelet valuesMajor adverse cardiac and cerebrovascular events
CategoricalBaseline platelet valuesMajor bleeding
CategoricalBaseline platelet valuesMinor bleeding
CategoricalBaseline platelet valuesMyocardial infarction
CategoricalBaseline platelet valuesNACE
CategoricalBaseline platelet valuesStent thrombosis
CategoricalBaseline platelet valuesunplanned revascularization

Please see downloadable data for more