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Table 2 Data collection schedule

From: The PARADIGHM (physicians advancing disease knowledge in hypoparathyroidism) registry for patients with chronic hypoparathyroidism: study protocol and interim baseline patient characteristics

Parameter Baseline visit Follow-up visit
Inclusion/exclusion criteria ×  
Informed consent, medical records release, and contact order form ×  
Demographicsa ×  
Other study participation × ×
Hypoparathyroidism etiology (primary cause)b ×  
Family history ×  
Medical history/condition summary ×  
Height and weight × ×
Pregnancy × ×
Clinical laboratory evaluations × ×
Other medical proceduresc × ×
Management of chronic hypoparathyroidism × ×
rhPTH(1-84) dosing informationd × ×
Historical PTH dosing informatione ×  
Prior and concomitant medications, including over-the-counter medications × ×
Outcome evaluations (socioeconomic status and social history) ×  
Outcome evaluations (Hypoparathyroidism Symptom Diary, WPAI:SHP, SF-36, SF-10) ×f ×
Other questionnaires (signs and symptoms, hospitalization annual form) × ×
Vital status database searches   ×g
Adverse events ×f,h ×
Patient discontinuation   ×
  1. PTH parathyroid hormone, rhPTH(1-84) recombinant human parathyroid hormone (1-84), SF-10 10-Item Short Form Health Survey questionnaire for pediatric patients, SF-36 36-Item Short Form Health Survey questionnaire for adults, WPAI:SHP Work Productivity and Activity Impairment Specific Health Problem
  2. aFor example, month and year of birth, age
  3. bGenetic mutation, surgery-induced, autoimmune, radiation, idiopathic, other
  4. cFor example, dual-energy x-ray absorptiometry, imaging, bone biopsies
  5. dRefers to the use of rhPTH(1-84) (Natpar®/Natpara®)
  6. eRefers to the use of rhPTH(1-84) (Preotact®) or rhPTH(1-34) (Forteo®)
  7. fDiscrepancy from November 2017 protocol to be corrected in future amendments
  8. gSearch is only performed if patient is a US patient lost to follow-up or reported deceased
  9. hClassification was at investigator discretion after the signing of the informed consent form (ie, adverse events should not be historical events before enrollment)