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ORIGINAL RESEARCH

Psychometric Analysis of the Patient-Reported Hypoparathyroidism Symptom Diary Symptom Subscale Using Data from Two Clinical Trials

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Pages 355-367 | Received 29 Mar 2023, Accepted 13 Oct 2023, Published online: 27 Nov 2023

References

  • Bilezikian JP, Khan A, Potts JT Jr, et al. Hypoparathyroidism in the adult: epidemiology, diagnosis, pathophysiology, target-organ involvement, treatment, and challenges for future research. J Bone Miner Res. 2011;26(10):2317–2337. doi:10.1002/jbmr.483
  • Shoback D. Clinical practice. Hypoparathyroidism. N Engl J Med. 2008;359(4):391–403. doi:10.1056/NEJMcp0803050
  • Bollerslev J, Rejnmark L, Zahn A, et al. European expert consensus on practical management of specific aspects of parathyroid disorders in adults and in pregnancy: recommendations of the ESE educational program of parathyroid disorders. Eur J Endocrinol. 2021;186(2):R33–R63. doi:10.1530/EJE-21-1044
  • Shoback DM, Bilezikian JP, Costa AG, et al. Presentation of hypoparathyroidism: etiologies and clinical features. J Clin Endocrinol Metab. 2016;101(6):2300–2312. doi:10.1210/jc.2015-3909
  • Gosmanova EO, Chen K, Ketteler M, et al. Risk of cardiovascular conditions in patients with chronic hypoparathyroidism: a retrospective cohort study. Adv Ther. 2021;38(8):4246–4257. doi:10.1007/s12325-021-01787-7
  • Gosmanova EO, Houillier P, Rejnmark L, Marelli C, Bilezikian JP. Renal complications in patients with chronic hypoparathyroidism on conventional therapy: a systematic literature review: renal disease in chronic hypoparathyroidism. Rev Endocr Metab Disord. 2021;22(2):297–316. doi:10.1007/s11154-020-09613-1
  • Fonseca OA, Calverley JR. Neurological manifestations of hypoparathyroidism. Arch Intern Med. 1967;120(2):202–206. doi:10.1001/archinte.1967.00300020074009
  • Arlt W, Fremerey C, Callies F, et al. Well-being, mood and calcium homeostasis in patients with hypoparathyroidism receiving standard treatment with calcium and vitamin D. Eur J Endocrinol. 2002;146(2):215–222. doi:10.1530/eje.0.1460215
  • Siggelkow H, Clarke BL, Germak J, et al. Burden of illness in not adequately controlled chronic hypoparathyroidism: findings from a 13-country patient and caregiver survey. Clin Endocrinol (Oxf). 2020;92(2):159–168. doi:10.1111/cen.14128
  • Buttner M, Krogh D, Siggelkow H, Singer S. What are predictors of impaired quality of life in patients with hypoparathyroidism? Clin Endocrinol (Oxf). 2022;97(3):268–275. doi:10.1111/cen.14701
  • Astor MC, Lovas K, Debowska A, et al. Epidemiology and health-related quality of life in hypoparathyroidism in Norway. J Clin Endocrinol Metab. 2016;101(8):3045–3053. doi:10.1210/jc.2016-1477
  • Vokes T. Quality of life in hypoparathyroidism. Bone. 2019;120:542–547. doi:10.1016/j.bone.2018.09.017
  • Buttner M, Musholt TJ, Singer S. Quality of life in patients with hypoparathyroidism receiving standard treatment: a systematic review. Endocrine. 2017;58(1):14–20. doi:10.1007/s12020-017-1377-3
  • Sikjaer T, Moser E, Rolighed L, et al. Concurrent Hypoparathyroidism is associated with impaired physical function and quality of life in hypothyroidism. J Bone Miner Res. 2016;31(7):1440–1448. doi:10.1002/jbmr.2812
  • Cusano NE, Rubin MR, McMahon DJ, et al. The effect of PTH(1-84) on quality of life in hypoparathyroidism. J Clin Endocrinol Metab. 2013;98(6):2356–2361. doi:10.1210/jc.2013-1239
  • Brod M, McLeod L, Markova D, et al. Psychometric validation of the Hypoparathyroidism Patient Experience Scales (HPES). J Patient Rep Outcomes. 2021;5(1):70. doi:10.1186/s41687-021-00320-2
  • Brod M, Waldman LT, Smith A, Karpf D. Assessing the patient experience of hypoparathyroidism symptoms: development of the Hypoparathyroidism Patient Experience Scale-Symptom (HPES-Symptom). Patient. 2020;13(2):151–162. doi:10.1007/s40271-019-00388-5
  • Wilde D, Wilken L, Stamm B, et al. The HPQ–development and first administration of a questionnaire for hypoparathyroid patients. JBMR Plus. 2020;4(1):e10245. doi:10.1002/jbm4.10245
  • Martin S, Chen K, Harris N, Vera-Llonch M, Krasner A. Development of a patient-reported outcome measure for chronic hypoparathyroidism. Adv Ther. 2019;36(8):1999–2009. doi:10.1007/s12325-019-00999-2
  • US Food and Drug Administration. Guidance for industry. Patient-reported outcome measures: use in medical product development to support labeling claims; 2009. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf. Accessed December 5, 2022.
  • Coles T, Chen K, Nelson L, et al. Psychometric evaluation of the hypoparathyroidism symptom diary. Patient Relat Outcome Meas. 2019;10:25–36. doi:10.2147/PROM.S179310
  • ClinicalTrials.gov. A study of extended use of recombinant human parathyroid hormone (rhPTH(1-84)) in hypoparathyroidism NCT02910466; 2021. Available from: https://clinicaltrials.gov/ct2/show/NCT02910466. Accessed October 5, 2022.
  • ClinicalTrials.gov. Safety and efficacy study of rhPTH(1-84) in subjects with hypoparathyroidism NCT03364738; 2022. Available from: https://clinicaltrials.gov/ct2/show/NCT03364738. Accessed October 5, 2022.
  • Bland JM, Altman DG. Statistics notes: Cronbach’s alpha. BMJ. 1997;314(7080):572. doi:10.1136/bmj.314.7080.572
  • Streiner DL. Starting at the beginning: an introduction to coefficient alpha and internal consistency. J Pers Assess. 2003;80(1):99–103. doi:10.1207/S15327752JPA8001_18
  • Koo TK, Li MY. A guideline of selecting and reporting intraclass correlation coefficients for reliability research. J Chiropr Med. 2016;15(2):155–163. doi:10.1016/j.jcm.2016.02.012
  • Cohen J. A power primer. Psychol Bull. 1992;112(1):155–159. doi:10.1037/0033-2909.112.1.155
  • National Health Service. Hypoparathyroidism; 2021. Available from: https://www.nhs.uk/conditions/hypoparathyroidism/. Accessed March 29, 2023.
  • Brod M, Waldman LT, Smith A, Karpf D. Living with hypoparathyroidism: development of the Hypoparathyroidism Patient Experience Scale-Impact (HPES-Impact). Qual Life Res. 2021;30(1):277–291. doi:10.1007/s11136-020-02607-1
  • Wilde D, Wilken L, Stamm B, et al. Quantification of symptom load by a disease-specific questionnaire HPQ 28 and analysis of associated biochemical parameters in patients with postsurgical hypoparathyroidism. JBMR Plus. 2020;4(7):e10368. doi:10.1002/jbm4.10368