{
"info": {
"nct_id": "NCT00471601",
"official_title": "Measuring Patient Expectations for Breast Reconstruction: Development and Validation of a Patient-Reported Outcomes Instrument",
"inclusion_criteria": "* Female.\n* Age > or = to 18 to 75 years.\n* Patients who are presenting for consultation about breast reconstruction\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "* Inability to speak or understanding English\n* Inability to provide meaningful informed consent due to physical, cognitive, or psychiatric disability.\n* Prior breast reconstruction surgery.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Female.",
"criterions": [
{
"exact_snippets": "Female",
"criterion": "gender",
"requirements": [
{
"requirement_type": "expected_value",
"expected_value": "female"
}
]
}
]
},
{
"line": "* Age > or = to 18 to 75 years.",
"criterions": [
{
"exact_snippets": "Age > or = to 18 to 75 years.",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 75,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "* Patients who are presenting for consultation about breast reconstruction",
"criterions": [
{
"exact_snippets": "Patients who are presenting for consultation about breast reconstruction",
"criterion": "consultation for breast reconstruction",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirements": [
{
"requirement_type": "expected_value",
"expected_value": "female"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 75 Years",
"criterions": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Inability to speak or understanding English",
"criterions": [
{
"exact_snippets": "Inability to speak ... English",
"criterion": "ability to speak English",
"requirements": [
{
"requirement_type": "ability",
"expected_value": false
}
]
},
{
"exact_snippets": "understanding English",
"criterion": "ability to understand English",
"requirements": [
{
"requirement_type": "ability",
"expected_value": false
}
]
}
]
},
{
"line": "* Inability to provide meaningful informed consent due to physical, cognitive, or psychiatric disability.",
"criterions": [
{
"exact_snippets": "Inability to provide meaningful informed consent",
"criterion": "ability to provide informed consent",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
},
{
"exact_snippets": "physical ... disability",
"criterion": "physical disability",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "cognitive ... disability",
"criterion": "cognitive disability",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "psychiatric disability",
"criterion": "psychiatric disability",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Prior breast reconstruction surgery.",
"criterions": [
{
"exact_snippets": "Prior breast reconstruction surgery.",
"criterion": "breast reconstruction surgery",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}