European Adrenal Insufficiency Registry (EU-AIR): a comparative observational study of glucocorticoid replacement therapy

Table 1 Data collection at baseline and at routine clinic visits

	Baseline	Routine clinic visits^a
Informed consent	√	×
Demographic information	√	×
AI diagnosis (aetiology and year of diagnosis)	√	×
Relevant medical history	√	×
Relevant concomitant disease^b	√	√
Glucocorticoid replacement therapy^c	√	√
Concomitant medication	√	√
Physical examination^d	√	√
Vital signs^e	√	√
Pregnancy status^f	√	√
Laboratory assessments^g	√	√
DEXA	√^h	√ⁱ

^aApproximately every 6 months or more frequently in cases of complications (e.g. adrenal crisis) or when changes to treatment are required.
^bDiabetes, hypertension, other hormone deficiencies, renal/hepatic impairment and disorders/diseases of gastrointestinal emptying/motility; year of diagnosis to be recorded.
^cGlucocorticoid replacement therapy to be specified (generic name), plus dosing regimen and start/stop dates. Patients are defined as naive or established on their current therapy on the basis of the threshold of < 90 days and ≥ 90 days of treatment exposure, respectively.
^dHeight (baseline only), body weight and waist circumference.
^eBlood pressure (systolic and diastolic) and heart rate.
^fRecorded at baseline, if available; as applicable post-baseline.
^gSodium, potassium and glycated haemoglobin are recorded in the eCRF at enrolment, if available; see Table 2 for other laboratory parameters to be recorded during the study, as available.
^hRecorded in the eCRF at baseline in patients identified as at high risk in centres routinely performing DEXA.
ⁱAs performed during routine clinic visits (every 2–3 years in patients identified as at high risk).
AI, adrenal insufficiency; DEXA, dual-energy X-ray absorptiometry; eCRF, electronic case report form.

ISSN: 1472-6823