Appendix Table. Inclusion and Exclusion Criteria According to Key Question *
| Question |
Criteria |
KQ 1, 2a, 3
(risk assessment) |
Include |
Risk models
Risk evaluation instrument
Practice standards or guidelines
Randomized, controlled trial
Comparative study (cohort, case-control, or observational study) with >50 participants
Overview, meta-analysis, or review with relevant information
Cost |
| Exclude |
Not applicable to U.S. primary care setting
Study limitations (small number of participants, noncomparative, single case report)
No data (commentary, letter, opinion)
Information not relevant (dated, off-topic) |
KQ 1, 2b, 3
(genetic counseling) |
Include |
Randomized, controlled trial
Comparative study (cohort, case-control, or observational study) with >50 participants
Overview, meta-analysis, or review with relevant information
Practice standards or guidelines
Cost |
| Exclude |
Not applicable to U.S. primary care setting
Study limitations (small number of participants, noncomparative, single case report)
No data (commentary, letter, opinion)
Information not relevant (dated, off-topic) |
KQ 1, 2c, 3
(genetic testing) |
Include |
Genetic testing for heritable clinically significant BRCA1 and/or BRCA2 mutations (excludes studies of tumor tissue only)
Participants from United States, Canada, United Kingdom, Australia, or Israel >50 participants |
| Exclude |
Risk model only
No primary data included (include meta-analysis)
Not BRCA1 or BRCA2
Not breast or ovarian cancer
No genetic testing
Only second cancer at same site (risk for second, contralateral cancer)
Basic science only (studies of gene function or gene expression)
Tumor tissue only
Linkage and/or segregation analysis (i.e., no testing for BRCA1 or BRCA2 mutations) |
KQ 4 and KQ 5
(interventions and adverse effects) |
Include |
Randomized, controlled trial
Comparative study (cohort, case-control, or observational study) with >50 participants
Overview, meta-analysis, or review with relevant information
Surveillance
Chemoprevention
Prophylactic surgery
Cost |
| Exclude |
Not applicable to U.S. primary care setting
Study limitations (small number of participants, noncomparative, single case report)
No data (commentary, letter, opinion)
Information not relevant (dated, off-topic) |
* KQ = key question.
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