Goiter, Thyroid Disease
Conditions
Keywords
Nodular goiter, Thyroidectomy, Dysphagia, Psychometrics, Rasch analysis
Brief summary
The goal of this observational study is to develop a questionnaire for measuring swallowing and throat discomfort symptoms in patients with goiter or thyroidectomy, which complies with the model of Rasch and which satisfies the fundamental measurement axioms (e.g., unidimensionality, linearity, generalizability). Developing a scale with such characteristics would provide clinicians and researchers with a reliable tool for assessing the impact of goiter and for measuring the outcomes after surgery. Also, the study will assess the psychological impact of goiter and thyroidectomy, as well as the characteristics of the surgical scar after thyroidectomy. The questionnaire will be developed in the first phase of the study. Items and response categories will be identified through interviews performed with patients affected by goiter or after thyroidectomy. In the following phases of the study, the questionnaire will be administered to patients before and after thyroidectomy.
Interventions
None listed
Sponsors
Istituto Auxologico Italiano
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of goiter or thyroidectomy.
Exclusion criteria
* Diagnosis of other neurological disorders or disorders involving the aerodigestive tract that could cause swallowing disorders. * Previous surgery of the neck or involving the aerodigestive tract.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome measure will be the questionnaire which will be developed in the first phase of the study itself. | In the week before surgery, three months after surgery, and six months after surgery. | The questionnaire will be administered to the recruited patients three times: in the week before surgery, three months after surgery, and six months after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient and Observer Scar Assessment Scale (POSAS) 2.0. | The POSAS 2.0 will be administered 10 days after surgery and 2 months after surgery. | The Patient and Observer Scar Assessment Scale (POSAS) 2.0. is an assessment scale that measures the quality of the scar from the perspectives of the patient and the clinician. It is made of two separate subscales, i.e., the Observer Scar Assessment Scale and the Patient Scar Assessment Scale. The Observer Scar Assessment Scale is made of 6 items, each scored 1 to 10 (total score 6 to 60, with higher scores indicating worse scar quality). The Patient Scar Assessment Scale is made of 7 items, each scored 1 to 10, divided in three subsets (total score 7 to 70, with higher scores indicating worse scar quality). |
| Depression Anxiety Stress Scales-21 (DASS-21). | The DASS-21 will be administered 10 days before surgery and 2 months after surgery. | The Depression Anxiety Stress Scales-21 (DASS-21) is an assessment scale used to measure the severity of symptoms of depression, anxiety and stress. It is made of 21 items, each scored 0 to 3 (total score 0 to 63, with higher scores for greater severity of depression, anxiety and/or stress. |
Countries
Italy
Contacts
Primary ContactStefano Scarano, MD
Backup ContactGianlorenzo Dionigi, MD
Outcome results
None listed