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. 2024 Aug 28;3(4):100334. doi: 10.1016/j.jacig.2024.100334

Table I.

PICOS study selection criteria

Domain Inclusion Exclusion
Population
  • Patients with asthma treated with biologics, including children and (young) adults

  • Patients with asthma not treated with biologics

Interventions
  • Licensed biologics, injected by patient and/or at home
    • Benralizumab
    • Dupilumab
    • Mepolizumab
    • Omalizumab
    • Reslizumab
  • Other biologics, if relevant

  • Inhaled or oral asthma drugs

Comparators
  • Licensed biologics, injected by patient and/or at home

  • Licensed biologics, regardless of location or person injecting

  • No comparator

  • Inhaled or oral asthma drugs

Outcomes
  • Clinical outcomes
    • Clinical measures (FEV1, FVC, blood eosinophil count)
    • Asthma symptoms/incidence of asthma exacerbation
    • Correct use
    • Adherence and compliance
    • Proportion with successful self-administration of biologic
    • Total number of AI administrations that failed
    • Reduction in OCS use
    • Safety: AE, SAE, systemic reactions, injection site reaction, self-reported pain, incidence of immunogenicity
    • Other as reported
  • Humanistic burden
    • Patient preferences
    • Patient treatment experience
    • Patient confidence in using the AI
    • Injection fear
    • Quality of life (AQLQ, ACQ, ACT, EQ-5D, SGRQ, SF-36)
    • Other as reported
  • Economic outputs
    • Total costs (sum of direct and indirect costs)
    • Direct costs
      • Doctor/hospital office
      • Nurse fees
      • Biologic Administration fees
    • Indirect costs
      • Work loss due to medical appointments
      • Opportunity loss due to medical appointments
      • Travel time and distance to appointments by medical setting (primary care physician, clinic, etc.)
    • Resource use
      • Physician visits
      • Specialist visits
      • Hospitalizations and length of stay
      • Emergency department visits
    • Others as reported
  • Outcomes not related to (comparative evidence) self-administration of injectables

Study design
  • All relevant (except exclusions)

  • Nonrelevant narrative reviews, notes, commentaries, editorials, SLRs

EQ-5D, Euro-QoL-5D; FVC, forced vital capacity; SF-36, short form 36; SGRQ, St George’s Respiratory Questionnaire.

Item listed under clinical, humanistic, and economic outcomes is not restrictive. Outcomes not listed but relevant for these broad topics can also be reasons to include publications.