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Psychometric evaluation of the hypoparathyroidism symptom diary

Authors Coles T, Chen K, Nelson L, Harris N, Vera-Llonch M, Krasner A, Martin S

Received 6 July 2018

Accepted for publication 17 November 2018

Published 29 January 2019 Volume 2019:10 Pages 25—36

DOI https://doi.org/10.2147/PROM.S179310

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Andrew Yee

Peer reviewer comments 3

Editor who approved publication: Dr Robert Howland


Theresa Coles,1 Kristina Chen,2 Lauren Nelson,1 Nimanee Harris,1 Montserrat Vera-Llonch,2 Alan Krasner,2 Susan Martin3

1RTI Health Solutions, Research Triangle Park, NC, USA; 2Shire Human Genetic Therapies, Lexington, MA, USA; 3RTI Health Solutions, Ann Arbor, MI, USA

Purpose: To conduct an initial psychometric evaluation of the reliability and validity of the Hypoparathyroidism Symptom Diary (HPT-SD).
Patients and methods: Data were collected during a cross-sectional, observational study. Participants with self-reported hypoparathyroidism (HPT) completed the HPT-SD, the Functional Assessment in Cancer Therapy–Cognitive Function (FACT-Cog), the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-Fatigue), and the Hospital Anxiety and Depression Scale (HADS) measures. Item- and scale-level internal consistency reliability, known-groups validity, and construct validity were evaluated. Subscales were identified and preliminary scoring algorithms were developed.
Results: The study included 52 participants (mean age, 51 years). Overall, the measurement properties of the HPT-SD were very good. Item-level response frequency distributions showed evidence of possible floor effects for four muscle-related symptom items. Inter-item correlations revealed a pattern of relationships among symptom items (r=0.3–0.8) and among impact items (r=0.5–0.7) and provided evidence for two HPT-SD subscales: Symptoms and Impacts. ­Construct validity correlations supported a priori convergent validity hypotheses (|r|≥0.4) between HPT-SD subscales and the FACT-Cog, FACIT-Fatigue, and HADS. Mean HPT-SD Symptom and Impact scores were in the expected direction and significantly different between subgroups of patients with high and low HPT disease severity.
Conclusion: Results indicate that the HPT-SD is an appropriate measure of HPT-related symptoms and impacts. Floor effects may be attributed to the observational study design: participants manage symptoms with calcium and active vitamin D supplements prior to an escalation in severity. Future studies should assess the HPT-SD measurement properties using longitudinal study designs.

Keywords: hypoparathyroidism, symptom, psychometric, validation, impacts, patient-reported outcome

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