Chronic inflammatory immune-mediated diseases and immunosuppressive drugs: What evidence would you like to see generated from real-world data?

Study type

• Study topic:
  Other
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘Not applicable’, further details on the study type:
  This study will employ a cross-sectional observational survey design conducted entirely online using Google Forms, capturing priorities and unmet needs among patients with IMIDs and clinicians (gastroenterologists, rheumatologists, dermatologists).
• If ‘other’, further details on the scope of the study:
  This work aims to identify and characterise current clinical areas that should be prioritized using RWD from both patient and clinician perspectives in IMIDs, using a dedicated survey administered to both groups. As a secondary objective, differences in p
• Data collection methods:
  No individual level data collected for the purpose of the study

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Additional medical condition(s):
  Immune-mediated inflammatory diseases

Population studied

• Short description of the study population:
  Patients with IMIDs and main specialists involved in the IMIDs treatment

Study design details

• Study design:
  This study will employ a cross-sectional observational survey design conducted entirely online using Google Forms, capturing priorities and unmet needs among patients with IMIDs and clinicians (gastroenterologists, rheumatologists, dermatologists).
• Main study objective:
  This work aims to identify and characterise current clinical areas that should be prioritized using RWD from both patient and clinician perspectives in IMIDs, using a dedicated survey administered to both groups. As a secondary objective, differences in prioritization distributions between clinicians and patients will be analyzed.
• Setting:
  The target population for this survey consisted of patients with a diagnosis of an IMID and clinicians involved in the management of IMIDs. For patients, the survey link will be distributed through patient associations, using newsletters and the association’s official website; for clinicians, the survey will be disseminated via scientific societies through their newsletters and institutional websites.
• Interventions:
  The questionnaire structure will employ a conditional branching based on respondent type (31 total questions across 5 sections), with prioritisation scales (0-5 ranking), multiple-choice, Likert-type scoring, and open-ended items for additional endpoints.; The development of the items is based on literature search and expert opinions. Firstly, the questions have been defined. Secondly, they have been validated by experts and patient organizations. To allow comparison between clinicians and patients regarding the unmet needs and the prioritization of real-world evidence, the same questions were provided but with some differences in terms of language:; - Clinician version: Technical language with precise medical terminology;; - Patient version: Simplified, accessible language tailored for non-technical comprehension.;