{
    "info": {
        "nct_id": "NCT06322160",
        "official_title": "The Role of tHyroid cAncer Specific Patient Concerns iNventory (PCI-TC) in Enhancing Shared decisiOn Making",
        "inclusion_criteria": "* Aged over 18\n* Both genders\n* Patients who are diagnosed of low-risk well-differentiated thyroid carcinoma (papillary thyroid carcinoma or follicular carcinoma) with size of 1-4cm. This is either:\n\n  1. Diagnosed pre-operatively by fine-needle aspiration cytology (FNAC) with Thy5 grade [see appendix for the Thy classification] or\n  2. Confirmed following diagnostic hemithyroidectomy\n* Able to communicate in spoken and written English\n\nInclusion criteria for clinician participants\n\n* Consultant head and neck and thyroid surgeons who directly involve in the diagnosis and/or management of low-risk well-differentiated thyroid cancer (papillary thyroid carcinoma or follicular carcinoma) with size of 1-4cm for at least ten patients per year.\n* Both genders\n* Able to communicate in spoken and written English\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients who are diagnosed with tumour with adverse features this includes:\n\n  * Tumour with poor differentiated cytology or variants with bad prognosis (tall cell, columnar cell, Hurthle cell, solid variant)\n  * Tumour, which is multifocal, bilateral, with extrathyroidal extension, with perineural or lymphovascular invasion.\n  * Tumour with clinically or radiologically involved nodes or distant metastases\n  * Tumour which is of a familial disease\n* Patient who is either Pregnant or breast-feeding\n* Patient with hyper- or hypothyroidism who is a candidate for surgery\n* Patient who is concurrently diagnosed with any medullary, anaplastic, lymphoma, or parathyroid disease\n* Patients who had previous thyroidectomy for reasons other than diagnostic hemithyroidectomy for their recent cancer diagnosis.\n* Patients who are cognitively impaired or have a mental health condition and are therefore unable to give consent\n* Patient who is not able to read write and speak English.\n\nExclusion criteria for clinician participants\n\n• Consultant surgeons who diagnose and/or manage low-risk well-differentiated thyroid cancer for less than ten patients per year.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Aged over 18",
            "criterions": [
                {
                    "exact_snippets": "Aged over 18",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Both genders",
            "criterions": [
                {
                    "exact_snippets": "Both genders",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are diagnosed of low-risk well-differentiated thyroid carcinoma (papillary thyroid carcinoma or follicular carcinoma) with size of 1-4cm. This is either:",
            "criterions": [
                {
                    "exact_snippets": "diagnosed of low-risk well-differentiated thyroid carcinoma",
                    "criterion": "thyroid carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "low-risk well-differentiated"
                        }
                    ]
                },
                {
                    "exact_snippets": "papillary thyroid carcinoma or follicular carcinoma",
                    "criterion": "thyroid carcinoma type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "papillary",
                                "follicular"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "size of 1-4cm",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "cm"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "cm"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Diagnosed pre-operatively by fine-needle aspiration cytology (FNAC) with Thy5 grade [see appendix for the Thy classification] or",
            "criterions": [
                {
                    "exact_snippets": "Diagnosed pre-operatively by fine-needle aspiration cytology (FNAC) with Thy5 grade",
                    "criterion": "Thy5 grade diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "fine-needle aspiration cytology (FNAC)"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "pre-operatively"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Confirmed following diagnostic hemithyroidectomy",
            "criterions": [
                {
                    "exact_snippets": "Confirmed following diagnostic hemithyroidectomy",
                    "criterion": "diagnostic hemithyroidectomy",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to communicate in spoken and written English",
            "criterions": [
                {
                    "exact_snippets": "Able to communicate in spoken and written English",
                    "criterion": "English communication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Inclusion criteria for clinician participants",
            "criterions": [
                {
                    "exact_snippets": "clinician participants",
                    "criterion": "participant type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "clinician"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Consultant head and neck and thyroid surgeons who directly involve in the diagnosis and/or management of low-risk well-differentiated thyroid cancer (papillary thyroid carcinoma or follicular carcinoma) with size of 1-4cm for at least ten patients per year.",
            "criterions": [
                {
                    "exact_snippets": "Consultant head and neck and thyroid surgeons",
                    "criterion": "consultant specialty",
                    "requirements": [
                        {
                            "requirement_type": "specialty",
                            "expected_value": [
                                "head and neck",
                                "thyroid"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "directly involve in the diagnosis and/or management",
                    "criterion": "involvement in diagnosis/management",
                    "requirements": [
                        {
                            "requirement_type": "involvement",
                            "expected_value": [
                                "diagnosis",
                                "management"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "low-risk well-differentiated thyroid cancer (papillary thyroid carcinoma or follicular carcinoma)",
                    "criterion": "thyroid cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "low-risk well-differentiated thyroid cancer",
                                "papillary thyroid carcinoma",
                                "follicular carcinoma"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "size of 1-4cm",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "cm"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "cm"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "at least ten patients per year",
                    "criterion": "patient volume",
                    "requirements": [
                        {
                            "requirement_type": "minimum patient volume",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "patients per year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Both genders",
            "criterions": [
                {
                    "exact_snippets": "Both genders",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to communicate in spoken and written English",
            "criterions": [
                {
                    "exact_snippets": "Able to communicate in spoken and written English",
                    "criterion": "English communication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "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 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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients who are diagnosed with tumour with adverse features this includes:",
            "criterions": [
                {
                    "exact_snippets": "diagnosed with tumour",
                    "criterion": "tumour",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adverse features",
                    "criterion": "adverse features",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumour with poor differentiated cytology or variants with bad prognosis (tall cell, columnar cell, Hurthle cell, solid variant)",
            "criterions": [
                {
                    "exact_snippets": "Tumour with poor differentiated cytology",
                    "criterion": "tumour cytology",
                    "requirements": [
                        {
                            "requirement_type": "differentiation",
                            "expected_value": "poor"
                        }
                    ]
                },
                {
                    "exact_snippets": "variants with bad prognosis (tall cell, columnar cell, Hurthle cell, solid variant)",
                    "criterion": "tumour variant",
                    "requirements": [
                        {
                            "requirement_type": "prognosis",
                            "expected_value": "bad"
                        },
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "tall cell",
                                "columnar cell",
                                "Hurthle cell",
                                "solid variant"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumour, which is multifocal, bilateral, with extrathyroidal extension, with perineural or lymphovascular invasion.",
            "criterions": [
                {
                    "exact_snippets": "Tumour, which is multifocal",
                    "criterion": "tumour multifocality",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "bilateral",
                    "criterion": "tumour laterality",
                    "requirements": [
                        {
                            "requirement_type": "laterality",
                            "expected_value": "bilateral"
                        }
                    ]
                },
                {
                    "exact_snippets": "extrathyroidal extension",
                    "criterion": "extrathyroidal extension",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "perineural or lymphovascular invasion",
                    "criterion": "invasion type",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "perineural",
                                "lymphovascular"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumour with clinically or radiologically involved nodes or distant metastases",
            "criterions": [
                {
                    "exact_snippets": "Tumour with clinically or radiologically involved nodes",
                    "criterion": "involved nodes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Tumour with ... distant metastases",
                    "criterion": "distant metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumour which is of a familial disease",
            "criterions": [
                {
                    "exact_snippets": "Tumour which is of a familial disease",
                    "criterion": "tumour",
                    "requirements": [
                        {
                            "requirement_type": "familial disease",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient who is either Pregnant or breast-feeding",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient with hyper- or hypothyroidism who is a candidate for surgery",
            "criterions": [
                {
                    "exact_snippets": "Patient with hyper- or hypothyroidism",
                    "criterion": "thyroid condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "hyperthyroidism",
                                "hypothyroidism"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "candidate for surgery",
                    "criterion": "surgery candidacy",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient who is concurrently diagnosed with any medullary, anaplastic, lymphoma, or parathyroid disease",
            "criterions": [
                {
                    "exact_snippets": "concurrently diagnosed with any medullary",
                    "criterion": "medullary disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "concurrently diagnosed with any ... anaplastic",
                    "criterion": "anaplastic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "concurrently diagnosed with any ... lymphoma",
                    "criterion": "lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "concurrently diagnosed with any ... parathyroid disease",
                    "criterion": "parathyroid disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who had previous thyroidectomy for reasons other than diagnostic hemithyroidectomy for their recent cancer diagnosis.",
            "criterions": [
                {
                    "exact_snippets": "previous thyroidectomy",
                    "criterion": "previous thyroidectomy",
                    "requirements": [
                        {
                            "requirement_type": "reason",
                            "expected_value": "other than diagnostic hemithyroidectomy for their recent cancer diagnosis"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are cognitively impaired or have a mental health condition and are therefore unable to give consent",
            "criterions": [
                {
                    "exact_snippets": "cognitively impaired",
                    "criterion": "cognitive impairment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "mental health condition",
                    "criterion": "mental health condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to give consent",
                    "criterion": "ability to give consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient who is not able to read write and speak English.",
            "criterions": [
                {
                    "exact_snippets": "not able to read",
                    "criterion": "ability to read English",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not able to ... write",
                    "criterion": "ability to write English",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not able to ... speak English",
                    "criterion": "ability to speak English",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Exclusion criteria for clinician participants",
            "criterions": [
                {
                    "exact_snippets": "clinician participants",
                    "criterion": "participant type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "clinician"
                        }
                    ]
                }
            ]
        },
        {
            "line": "• Consultant surgeons who diagnose and/or manage low-risk well-differentiated thyroid cancer for less than ten patients per year.",
            "criterions": [
                {
                    "exact_snippets": "Consultant surgeons who diagnose and/or manage low-risk well-differentiated thyroid cancer",
                    "criterion": "consultant surgeon specialty",
                    "requirements": [
                        {
                            "requirement_type": "specialty",
                            "expected_value": "diagnose and/or manage low-risk well-differentiated thyroid cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "less than ten patients per year",
                    "criterion": "patient volume",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 10,
                                "unit": "patients per year"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}