Objectives: Validation of a German version of the ThyPRO-39 questionnaire for quality of life (QoL) in patients with benign thyroid diseases.
Design: Internal consistency, retest-reliability and validity were to be assessed in a test-retest study.
Methods: The ThyPRO-39 was translated based on standard methodology. A sample of 98 patients with benign thyroid diseases was tested with the ThyPRO-39de and the generic EuroQol 5D-5L. 44 patients with stable symptoms after 2 weeks formed the repeated-measures sample. Cronbach’s alpha was calculated for the ThyPRO-39de composite score and for each disease specific scale. Intraclass correlations between the original and the repeated measures sample were calculated for each scale as well as Pearson correlations between various ThyPRO scales and the EuroQol. T-Tests were used to test for differences in the goiter and hyperthyroid symptom scales between relevant patient groups and other patients.
Results: Internal consistency was between satisfactory and good, except for two scales (Tiredness and Cosmetic complaints/appearance). The test-retest correlation was between 0.62 and 0.8 for most scales, but below 0.5 for two scales (Tiredness and Impaired social life). There were significant correlations between the EuroQol index score and most aspects of the ThyPRO-39de. Only hyperthyroid symptoms scale was specific for the relevant patient group (Graves’ disease).
Conclusion: The ThyPRO-39de may be recommended for use in clinical and research settings, especially with regards to the composite score. However, the underlying thyroid disease should always be kept in mind when interpreting the test results. A larger sample would be needed to implement further improvements.
Background: We want to investigate if a routine preoperative dietary supplementation of calcium and magnesium prior to thyroidectomy for nodular goiter and graves' disease can influence patients' outcome with regards to hypocalcemia associated symptoms and quality of life in order to reduce the risk of post-thyroidectomy hypocalcemia and to improve patient's quality of life.Methods: The study will be conducted as a two-armed randomized controlled trial including patients scheduled for total thyroidectomy. Patients assigned to the intervention group will receive calcium carbonate and magnesium oxide starting 2 weeks preoperatively. Primary outcome is the postoperative quality of life measured by the ThyPRO-39 and EQ-5D questionnaires. Secondary outcome is the assessment of postoperative biochemical (calcium and PTH levels) and clinical hypocalcemia (symptoms as reported by the patient).Discussion: A prophylactic dietary supplementation with calcium and magnesium, which could easily be implemented in the preoperative setting, could potentially help to avoid or reduce hypocalcemia-associated symptoms and improve quality of life. In the event of a positive outcome, this preoperative procedure can be an inexpensive way to prepare patients scheduled for thyroidectomy and can possibly reduce disease-specific costs by reducing the postoperative complication rate.Clinical Trial Registration: DRKS00017195 in the German clinical trials register (Deutsches Register Klinischer Studien, DRKS) on the 22.05.2019.
• BackgroundWe want to investigate if a routine preoperative dietary supplementation of calcium and magnesium prior to thyroidectomy for nodular goiter and grave´s disease can influence patients’ outcome with regards to hypocalcemia associated symptoms and quality of life in order to reduce the risk of post-thyroidectomy hypocalcemia and to improve patient`s quality of life.• MethodsThe study will be conducted as a two-armed randomized controlled trial with patients scheduled for total thyroidectomy. The patients assigned to the intervention group will receive calcium carbonate and magnesium oxide, and will begin the intake 2 weeks preoperatively. Primary outcome is the postoperative quality of life measured by using the ThyPRO-39 and EQ-5D questionnaires. Secondary outcome is the assessment of postoperative biochemical (calcium and PTH levels) and clinical hypocalcemia (symptoms as reported by the patient).• DiscussionA prophylactic dietary substitution with calcium and magnesium, which could easily be done in the preoperative setting, could potentially help to avoid or reduce hypocalcemia-associated symptoms and improve quality of life. In the event of a positive outcome, this preoperative procedure can be an inexpensive way to prepare patients scheduled for thyroidectomy and can possibly reduce disease-specific costs by reducing the postoperative complication rate.• Trial registration: DRKS00017195 in the German clinical trials register (Deutsches Register Klinischer Studien, DRKS) on the 22.05.2019.
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