Quality of life in patients with postsurgical hypoparathyroidism

Rationale: Hypoparathyroidism is caused by absent or insufficient amounts of parathyroid hormone. This is a relatively rare disease, but unfortunately a common complication after thyroid surgery due to inadvertent damage to the parathyroid glands. Although the relatively easy treatment with calcium supplementation suggests that the burden of disease is low, Hadker et al. assessed 374 adults with hypoparathyroidism (of which 80% was due to surgical interference) and found that despite medical treatment, patients did not function well in their day-to-day life. Currently, epidemiological studies are sparse and quality of life studies are slowly advancing. The possible future treatment of these patients with synthetic PTH renders is important to assess the burden of disease and quality of life in a matched control study.
Objective: The objective is to assess the impact of hypoparathyroidism on quality of life and the burden of disease.
Study design: A prospective observational case-control study will be performed.
Study population: All adult patients with persisting hypoparathyroidism and a matched cohort without hypoparathyroidism, who underwent a total or completion thyroidectomy are eligible for inclusion.
Intervention: Not applicable
Main study parameters/endpoints: Main study endpoints are quality of life in patients with hypoparathyroidism as measured by the physical component score of the SF-36, thyroid related quality of life (ThyPro), functional and cognitive assessment (CIS and PROMIS) and burden of disease as measured by EQ-5D-5L. Other endpoints are extra hospital visits, employment status, comorbidities and hypoparathyroidism related laboratory parameters.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will be asked to visit the outpatient department one time at the beginning of inclusion. If possible, this visit will be combined with a regular care visit. During this visit a venipuncture will be performed and in total 5 tubes of blood will be drawn. Risks associated with venipunctures are hematoma and pain. Patients will also be asked to fill in five questionnaires at three time points. Furthermore, patients will receive a phone call every three months to answer questions regarding their employment status, medication, comorbidities and extra hospital visits. There is no direct benefit for the patients.

It is expected that patients with hypoparathyroidism have a lower quality of life.

The duration of patient participation will be up to 1 year. Patients will be asked to visit the Erasmus Medical Center at baseline and to fill in questionnaires at three time points (baseline, 6 months, 12 months).