Patients’, physicians', nurses’ and pharmacists’ preferences toward the attributes of biological agents used in the treatment of rheumatic diseases in Italy (MK-0000-330) (CARA)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Descriptive, observational, cross-sectional, open, multicenter, stated preferences study

Study drug and medical condition

• Medical condition to be studied:
  Rheumatoid arthritis

  Ankylosing spondylitis

Population studied

• Short description of the study population:
  The study sample included 1) patients, 2) rheumatologists, 3) nurses and 4) pharmacists meeting the inclusion criteria and the characteristics necessary according to the objective of the study.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  740

Study design details

• Main study objective:
  The primary objective is to assess the most preferred attributes and the importance of biologics for the management of rheumatic diseases in a real setting according to the different treatment characteristics and points of view and experiences of the different categories of involved subjects (patients, physicians, nurses and pharmacists).
• Outcomes:
  1) To estimate the relative importance according to preferences assigned to the attributes of biological treatments and to explore differences and similarities between the different categories of participants: patients, physicians, nurses and pharmacists. 2) To identify socio-demographic, clinical and other characterisitics that may influence paitient preferences for treatment.
• Data analysis plan:
  The statistical package STATA will be used to conduct the analysis. For all statistical tests, a p-value <0.05 will be considered statistically significant. Missing data (e.g. dubious, ambiguous, inconsistent) on socio-demographic and clinical information will be properly identified (e.g. “99”) in the data base and specified in the final report of study results. Unclear data will be traced back, addressed with the participating rheumatologist, and contrasted with the patient’s health record (whenever possible). If data amendment is not possible, data will be regarded as missed.