Table 2

Recommendations on monitoring including method and interval

Assessments and feasible methods of monitoringMinimal monitoring frequency
Adverse eventClinical trialsDaily practice (if different from clinical trials)Clinical trialsDaily practice
Cardiovascular
 DyslipidemiaBlood: fasting lipids–Start, end–
 Electrolyte disturbancesBlood: sodium and potassium–Start, end–
 EdemaPhysical examination: ankle edema–Start, endStart
 HypertensionBlood pressure measurement–Start, endStandard care
 Ischemic CVD

  1. Questioning

  2. Carotid intima-media thickness*

Questioning

  1. Start, end

  2. Start, end**

Standard care
Infectious
 InfectionsQuestioning: occurrence, treatment with antibiotics–Start, during follow-up–
Gastro-intestinal
 Peptic ulcer disease

  1. Questioning: complaints

  2. Blood: haemoglobin

–

  1. Start, end

  2. Start, end

Standard care
Psychological
 Mood disturbancesQuestioning–Start, end–
 PsychosisActive monitoring not indicated; report of occurrence–––
Endocrine and metabolic
 Diabetes/glucose intoleranceBlood: fasting glucose and insulin (HOMA)Blood: fasting glucoseStart, endStart, standard care
 Body weight and fat redistribution

  1. Height

  2. Weight

  3. Abdominal circumference

  1. Height

  2. Weight

  1. Start, end

  2. Start, during follow-up

  3. Start, end

Standard care
 Interference with hormone secretion

  1. Questioning: menstrual disturbances/loss of libido

  2. Blood: ACTH stimulation test*

–

  1. Start, end

  2. Start, within 48 h after stopping

–
Dermatological
 Skin atrophy

  1. Questioning

  2. Sonography for skin thickness (volar part of arm)*

–

  1. Start, end

  2. Start, end**

–
 Acne, hirsutism, alopecia, bruisabilityQuestioning–Start, end–
 HirsutismQuestioning–Start, end–
Musculo skeletal
 Osteoporosis (BMD)

  1. DEXA

  2. X-rays dorsal spine (if possible)

  3. Questioning for fractures

–

  1. Start, end** (for newly started GCs: also at six months)

  2. Start, end

  3. Start, end

Standard care according to local guidelines
 OsteonecrosisActive monitoring not indicated; imaging only in case of complaints–––
 MyopathyQuestioning–Start, end–
Ophthalmological
 CataractOphthalmologic evaluation–Start, end**–
 Glaucoma (intra-ocular pressure)Ophthalmologic evaluation with tonometryQuestioning for risk factors: family history, high myopia, diabetesStart, end**Start (ophthalmologic evaluation in case of risk factors)

  • ↵* This is the preferable monitoring method, but probably less feasible. We ask to incorporate at least one of these items in future trials.

  • ↵** Monitoring is only indicated for studies with a duration of at least 1 year.

  • For all adverse events (AEs) feasible monitoring methods are described and preferable monitoring intervals are given. These are minimum recommendations, indicating that they can be intensified for patients with additional risk factors for a certain AE. In most cases monitoring is recommended at start and at the end of trials. In case of drop-out, the ‘end’-monitoring should be performed at time of drop-out. Broad explanation about these recommendations is enclosed in Online Appendix 2. In Online Appendix 3 suggestions for questioning are given.

  • ACTH, adrenocorticotropic hormone; BMD, bone mineral density; CVD, cardiovascular disease; GCs, glucocorticoids; HOMA, homeostasis model assessment.