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Table 1 Primary and secondary outcomes, measures and timepoints

From: Protocols of a diagnostic study and a randomized controlled non-inferiority trial comparing televisits vs standard in-person outpatient visits for narcolepsy diagnosis and care: TElemedicine for NARcolepsy (TENAR)

OutcomesMeasuresTimepoints (months)
Primary
 EDSESS (adults) [28]
ESS-CHAD [32] (adolescents)
0, 3, 6, 9, 12 incident patients
0, 6, 12 prevalent patients
Secondary
 Other symptomsCataplexy diary, NSS [33], BDI [34], STAI [35] (adults)
CDI2 [36], MASC [37] (adolescents)
Global Impression Scale [38] (physicians)
0, 3, 6, 9, 12 incident patients
0, 6, 12 prevalent patients
 Compliance to treatmentClinical consultation0, 3, 6, 9, 12 incident patients
0, 6, 12 prevalent patients
 WeightStandard weight scale provided to each patient0, 3, 6, 9, 12 incident patients
0, 6, 12 prevalent patients
 Lipidic/glycaemic control*Laboratory tests0, 12
 Caloric intakeFood diary0, 12 [0, 3, 6, 9, 12 patients with metabolic problems]
 Physical activityShort-IPAQ [29]0, 12 [0, 3, 6, 9, 12 patients with metabolic problems]
 Satisfaction indexCoTenar (patients and caregiver)**6, 12
 Quality of lifeSF-36 (adults) [39]
PedsQL [40] (adolescents)
0, 6, 12
 Number (%) of full dropouts At the time of censorship
 Number (%) of partial dropouts (patients changing procedure) At the time of arm change
 Adverse drug reactionsClinical consultation0, 3, 6, 9, 12 incident patients
0, 6, 12 prevalent patients
 Costs and accidentsInterview (patients and caregivers)0, 6, 12
 Other feasibility indexesFailure system report (physicians and patients)After each TV
  1. *Glucose, insulin, HbA1c, triglycerides, total, LDL and HDL cholesterol, TSH, glycaemia, insulin, glycated haemoglobin, HDL, triglycerides, total, LDL, uricemia, TSH, FT4, FT3, complete blood count, AST, ALT, gamma-GT, alkaline phosphatase, creatinine. ** Adapted from CoSM-S [41]