Extraction form for project: Breast cancer and cardiovascular outcomes

Design Details

N/A

Arm Details

1. Follow-up period
Please, provide folow-up period in years. If it is reported only for different study groups, overall follow-up could be calculated easily with the following link - https://www.statstodo.com/CombineMeansSDs.php (Javascript Program)
Breast cancer patients :
Follow-up period
Comments
2. Country
Breast cancer patients :
3. Study design
Please, provide the design of the study
Breast cancer patients :
Multiple Choice
Randomized Controlled study
Pooled analysis of RCTs
Prospective cohosrt study
retrospective cohosrt study
Registry-based
Single-center
Multicenter
Nationalwide
Other (please, indicate)
Not reported
4. Key inclusion criteria
Breast cancer patients :
5. Key exclusion criteria
Breast cancer patients :
6. Is protocol for the study available in public registries?
Breast cancer patients :
Is protocol for the study available in public registries?
Single Choice
Yes
No
Unknown
Other
Comments (Registry number, etc)
7. Recruitment period
The years when study population was recruited
Breast cancer patients :
8. SEER based study?
Breast cancer patients :
Single Choice
Yes
No

Sample Characteristics

1. Sample size
Please, provide the sample size of total breast cancer population
Breast cancer patients :
2. Age
If it is reported only for different study groups, overall mean age could be calculated easily with the following link - https://www.statstodo.com/CombineMeansSDs.php (Javascript Program)
Breast cancer patients :
Mean age of the population
standard deviation
% of different age categories
Comments
3. Males (percentage)
Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups
Breast cancer patients :
Males (percentage)
Comments
4. Percentage of patients with postmenopausal status
Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups
Breast cancer patients :
Percentage
Comments
5. Race
Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups
Breast cancer patients :
White (Caucasian)
Hispanic
African–American (Black)
Asian
Comments
6. History of ischemic heart disease (percentage)
Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups
Breast cancer patients :
percentage
Comments
7. History of cardiac disease
Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups
Breast cancer patients :
Percentage
Comments
8. History of diabetes (percentage)
Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups
Breast cancer patients :
Percentage
Comments
9. Hypertension
Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups
Breast cancer patients :
Percentage
Comments
10. Smoking
Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups
Breast cancer patients :
Percentage
Comments
11. Alcohol
Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups
Breast cancer patients :
Percentage
Comments
12. Dyslipidemia (if not reported - use of lipid-lowering therapy)
Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups
Breast cancer patients :
Percentage
Comments
13. Atrial fibrillation
Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups
Breast cancer patients :
Percentage
Comments
14. Prior myocardial infarction (baseline characteristics)
Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups
Breast cancer patients :
Percentage
Comments
15. Previous heart failure
Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups
Breast cancer patients :
Percentage
Comments
16. Previous stroke
Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups
Breast cancer patients :
Percentage
Comments
17. Peripheral artery disease
Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups
Breast cancer patients :
Percentage
Comments
18. Valvular heart disease
Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups
Breast cancer patients :
Percentage
Comments
19. Abnormal renal function
Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups
Breast cancer patients :
Percentage
Comments
20. Charlson Comorbidity Index
Breast cancer patients :
Mean value
percentage for different categories
21. History of hormonal replacement therapy (percentage)
Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups
Breast cancer patients :
Percentage
Comments
22. Body mass index (mean value)
If it is reported only for different study groups, overall mean value and deviation could be calculated easily with the following link - https://www.statstodo.com/CombineMeansSDs.php (Javascript Program)
Breast cancer patients :
Mean value
Standard deviation
Overweight percentage
Comments
23. Breast cancer stage (percentage)
Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups
Breast cancer patients :
Stage 0 (ductal carcinoma in situ)/ local
Stage I (local)
Stage II (regional)
Stage III (regional)
Stage IV (distant/metastatic)
Local/Regional/distant
Comments
24. Tumor differentiation grade
Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups
Breast cancer patients :
Good - 1
Moderate - 2
Poor - 3
Comments
25. Type of breast cancer
Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups
Breast cancer patients :
Estrogen receptor positive
Progesteron receptor positive
Her2 positive
Triple negative
Any hormon receptor positive
Comments
26. Axillary lymph node status
Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups
Breast cancer patients :
negative
positive
comments
27. Laterality of breast cancer
Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups
Breast cancer patients :
Left-sided
Right-sided
Both sides
Comments
28. Size of breast tumor
Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups
Breast cancer patients :
< 2 cm
2-5 cm
> 5 cm
Comments
29. Type of surgical treatment
Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups
Breast cancer patients :
Surgery (percentage)
Mastectomy
Breast-conserving surgery
Ovarian ablation
axillary lymph node dissection
Comments
30. Anti-cancer systemic treatment
Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups
Breast cancer patients :
Adjuvant systemic treatment (after surgery), %
Neoadjuvant systemic treatment (before surgery), %
Any endocrine/hormonal therapy (tamoxifen/aromotase inhibitor), %
Tamoxifen use, %
Other aromatase inhibitor use, %
Chemotherapy (antracycline/taxane/cyclophosphamide based), %
Antracycline use, %
Any Anti-HER2 therapy (Trastuzumab/pertuzumab/neratinib/etc)
Trastuzumab use, %
Comments
31. Radiation therapy
Please, provide percentage for total breast cancer study population. If not reported, please, calculate by combining numbers for different study groups
Breast cancer patients :
Adjuvant radiotherapy, %
Total radiation dose (mean)
Moderate hypofractionation schedules, %
Techniques
Comments

Outcome Details

1. What is the definitions for the particular outcome?
Cardiovascular death:
2. How were outcomes assessed?
Cardiovascular death:
Method o assessment
Multiple Choice
National Death Registry
Clinical follow-up visits
Telephone interviews
Questionnaire, outcomes were self-reported by patients
Medical records
Electronic Health Record System
Other methods (please specify)
Not reported
Comments
3. Were outcomes measured in a blinded manner?
Cardiovascular death:
Multiple Choice
Yes, blinded
No, unblinded
Other
Not reported

Risk of Bias Assessment

1. Representativeness of the exposed cohort
Rating
Single Choice
Potential for selection biases or not stated
Consecutive eligible participants were selected, participants were randomly selected, or all participants were invited to participate from the source population*
Notes/Comments:
2. Selection of the non exposed cohort
Rating
Single Choice
No description
Selected from the same source population*
Selected from a different source population
Notes/Comments:
3. Ascertainment of exposure
Rating
Single Choice
No description
Structured injury data (eg record completed by medical staff)*
Structured interview*
Written self report
Notes/Comments:
4. Demonstration that outcome of interest was not present at the start of the study
Rating
Single Choice
Yes*
No or not explicitly stated
Notes/Comments:
5. Comparability of cohorts on the basis of the design or analysis
Note: Exposed and non-exposed individuals must be matched in the design and/or confounders must be adjusted for in the analysis. Alone statements of no differences between groups or that differences were not statistically significant are not sufficient.
Rating
Single Choice
Study controls for previous injury*
Study controls for age*
Notes/Comments:
6. Assessment of outcome
Rating
Single Choice
No description
Independent or blind assessment stated, or confirmation of the outcome by reference to secure records (e.g. imaging, structured injury data, etc)*
Record linkage (eg identified through ICD codes on database records)*
Self report with no reference to original structured injury data or imaging
Notes/Comments:
7. Was follow-up long enough for outcomes to occur
Rating
Single Choice
Yes (>=3 months)*
No (<3 months)
Notes/Comments:
8. Adequacy of follow up of cohorts
Rating
Single Choice
Complete follow up - all participants accounted for*
No statement
Subjects lost to follow up unlikely to introduce bias (<15% lost to follow up, or description provided to those lost)*
Follow up rate <85% and no description of those lost provided
Notes/Comments:

Suggested Arms

NameDescription
Breast cancer patients
General Population
Total All Arms combined

Please see downloadable data for more

Suggested Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)
Categoricalatrial fibrillation incidence
CategoricalCardiovascular death
CategoricalCoronary artery disease incidence
CategoricalCVD total
Categoricalheamorrhagic stroke incidence
CategoricalIschemic stroke incidence
Categoricalmyocardial infarction incidence
CategoricalStroke incidence
CategoricalSymptomatic heart failure incidence

Please see downloadable data for more