Extraction form for project: Breast cancer and cardiovascular outcomes

Design Details

N/A

Arms

Arm NameArm Description
Breast cancer patients

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)
Follow-up period
Comments
2. Country
3. Study design
Please, provide the design of the study
4. Key inclusion criteria
5. Key exclusion criteria
6. Is protocol for the study available in public registries?
Is protocol for the study available in public registries?
Comments (Registry number, etc)
7. Recruitment period
The years when study population was recruited
8. SEER based study?

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

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalCardiovascular death
  • All Participants
  • long-term follow-up
CategoricalCoronary artery disease incidence
  • All Participants
  • long-term follow-up
CategoricalSymptomatic heart failure incidence
  • All Participants
  • long-term follow-up

Outcome Details

1. What is the definitions for the particular outcome?
Cardiovascular death
Coronary artery disease incidence
Symptomatic heart failure incidence
2. How were outcomes assessed?
Cardiovascular death
Method o assessment
Comments
Coronary artery disease incidence
Method o assessment
Comments
Symptomatic heart failure incidence
Method o assessment
Comments
3. Were outcomes measured in a blinded manner?
Cardiovascular death
Coronary artery disease incidence
Symptomatic heart failure incidence

Risk of Bias Assessment

1. Representativeness of the exposed cohort
Rating
Notes/Comments:
2. Selection of the non exposed cohort
Rating
Notes/Comments:
3. Ascertainment of exposure
Rating
Notes/Comments:
4. Demonstration that outcome of interest was not present at the start of the study
Rating
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
Notes/Comments:
6. Assessment of outcome
Rating
Notes/Comments:
7. Was follow-up long enough for outcomes to occur
Rating
Notes/Comments:
8. Adequacy of follow up of cohorts
Rating
Notes/Comments:

Results

Categorical


Cardiovascular death

All Participants
Descriptive StatisticsBetween Arm Comparisons
Breast cancer patients
long-term follow-up
SMR
Odds Ratio (OR)
Total (N analyzed)
95% CI low (OR)
Events
95% CI high (OR)
Percentage
p value
Within Arm ComparisonsNet Comparisons
Breast cancer patients

Coronary artery disease incidence

All Participants
Descriptive StatisticsBetween Arm Comparisons
Breast cancer patients
long-term follow-up
SMR
Odds Ratio (OR)
Total (N analyzed)
95% CI low (OR)
Events
95% CI high (OR)
Percentage
p value
Within Arm ComparisonsNet Comparisons
Breast cancer patients

Symptomatic heart failure incidence

All Participants
Descriptive StatisticsBetween Arm Comparisons
Breast cancer patients
long-term follow-up
SMR
Odds Ratio (OR)
Total (N analyzed)
95% CI low (OR)
Events
95% CI high (OR)
Percentage
p value
Within Arm ComparisonsNet Comparisons
Breast cancer patients