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1
RTI Health Solutions, Research Triangle Park, NC, USA.
2
Department of Endocrinology, Diabetes and Metabolism, Ohio State University Wexner Medical Center, Columbus, OH, USA.
3
Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA.
4
RTI Health Solutions, Ann Arbor, MI, USA.
5
Takeda Pharmaceuticals U.S.A., Inc., Lexington, MA, USA.
6
Takeda Development Center Americas Inc., Lexington, MA, USA.
1
RTI Health Solutions, Research Triangle Park, NC, USA.
2
Department of Endocrinology, Diabetes and Metabolism, Ohio State University Wexner Medical Center, Columbus, OH, USA.
3
Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA.
4
RTI Health Solutions, Ann Arbor, MI, USA.
5
Takeda Pharmaceuticals U.S.A., Inc., Lexington, MA, USA.
6
Takeda Development Center Americas Inc., Lexington, MA, USA.
The hypoparathyroidism symptom diary (HypoPT-SD) is a disease-specific patient-reported outcome (PRO) tool comprising a 7-item symptom subscale, a 4-item impact subscale and 1-item anxiety, and sadness or depression components. This analysis assessed the psychometric properties of the HypoPT-SD symptom subscale scores using data from two open-label, single arm, Phase 4 studies (Study 402 and Study 404).
Eligible patients were aged 18 years or older with a confirmed diagnosis of hypoparathyroidism. All patients received recombinant human parathyroid hormone (1-84) during the analysis period. Scores were recorded at baseline, and at months 6, 30 and 36 (end of treatment [EOT]) in Study 402, and at baseline and week 52 (EOT) in Study 404. The structure of the HypoPT-SD Symptom subscale was analyzed by measuring correlations between pairs of item scores; internal consistency and reliability were evaluated using Cronbach's coefficient α; test-retest reliability was assessed using intraclass correlation; and construct validity was determined by performing correlational analyses between scores recorded using the HypoPT-SD and those for other conceptually similar PRO tools.
A total of 60 patients were included in the analysis. Inter-item pairwise correlations were strong for all but 5 of the item pairs analysed. Cronbach's α values for the HypoPT-SD Symptom subscale were 0.88 using data from Study 402 and 0.92 using data from Study 404. In general, the HypoPT-SD Symptom subscale scores had moderate or strong correlations with scores recorded using PRO tools. Intraclass correlation coefficients exceeded 0.70 using test-retest data from all patients in Study 402 and from a subgroup of patients with stable disease from Study 404.
Lauren Nelson and Susan Martin are employed by RTI Health Solutions. Jia Ma is a former employee of RTI Health Solutions and is now affiliated with Pfizer, USA. Steven W Ing is an advisory board member for, and received research grant support from, Takeda Pharmaceuticals USA, Inc. Mishaela R Rubin is a study investigator for Takeda Pharmaceuticals USA, Inc. and Ascendis Pharma. Rohini Sen is a former employee of Takeda Pharmaceuticals USA, Inc. and is now affiliated with AbbVie, USA. Olulade Ayodele is an employee of Takeda Development Center Americas Inc. and holds stocl/stock options in Takeda. The authors report no other conflicts of interest in this work.
