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Table 1 Instruments for measuring clinical efficacy and cost-effectiveness

From: Cost-effectiveness of the mobile application TCApp combined with face-to-face CBT treatment compared to face-to-face CBT treatment alone for patients with an eating disorder: study protocol of a multi-centre randomised controlled trial

Dimension Methodology Assessment measures Stakeholder T0 T1 T2
Clinical efficacy
 Psychopathology Clinical interview Minors (6-18 years old): Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL) (DSM-5)
Adults: Structured Clinical Interview for DSM Disorders (SCID-I)
Patient x   
 Physical and clinical variables Brief clinical interview Comorbidities, medication, illness duration, Body Mass Index, among others Patient x x x
 Eating Disorder psychopathology Questionnaire - Eating Disorders Examination Questionnaire (EDE-Q)
- Short Evaluation of Eating Disorders (SEED)
Patient x x x
 Depression Questionnaire Beck Depression Inventory-II (BDI-II) Patient x x x
 Anxiety Questionnaire State-Trait Anxiety Inventory (STAI) Patient x x x
 Motivation to change Questionnaire Patients with Anorexia Nervosa: Anorexia Nervosa Stages of Change Questionnaire (ANSOCQ)
Patients with Bulimia Nervosa or Binge Eating Disorder: Bulimia Nervosa Stages of Change Questionnaire (BNSOCQ)
Patient x x x
 Dropout Telephone interview Reasons for dropout Clinician responsible for the online monitoring   x x
 Risk of suicide Questionnaire Beck Hopelessness Scale (BHS) / Suicide Intent Scale (SIS) Patient / Clinician responsible for the online monitoring x x x
 Quality of life Questionnaire 12-14 years old: EQ-5D-Y (children version)
> 14 years old: EQ-5D-5 L
Patient x x x
 Caregiving experience Questionnaire Experience of Caregiving Inventory (ECI) Family caregiver x x x
 Quality of life Questionnaire EQ-5D-5 L Family caregiver x x x
Cost-utility and cost-effectiveness analysis
 Cost related to the development and maintenance of the online platform Telephone interview Staff involved, number of extra hours x pay rate/hour Technical staff x x  
 Costs related to healthcare utilization, medication and school and / or work absenteeism Questionnaire iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P) / iMTA questionnaire for Costs associated with Psychiatric Illness, Parent-Form (TiC-P Children) Adult patient / family caregiver (referring to minor patient) x x x
 Patient’s healthcare utilization Telephone interview Number of visits to ED specialists, number of visits to the emergency department, medication consumption and its costs Clinician responsible for the online monitoring x x x
 Cost of implementing the online intervention Telephone interview Clinicians involved, number of extra hours for online monitoring x pay rate/hour Clinician responsible for the online monitoring   x  
 Usability and satisfaction Questionnaire - Client Satisfaction Questionnaire (CSQ-8)
- System Usability Scale (SUS)
ED specialists and patients from the experimental group   x