Characterising Patient Pathways to the Diagnosis of Idiopathic Pulmonary Fibrosis: Real World Data Study

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Idiopathic pulmonary fibrosis

Population studied

• Short description of the study population:
  Patients with an Idiopathic Pulmonary Fibrosis (IPF) diagnosis code.; All patients must fulfil the following inclusion criteria:; 1. A diagnostic Read code for IPF (specific or broad definition) on or before 1st May 2017; 2. ≥1 year of continuous data prior to the index date; 3. Age ≥30 years at index date; 4. Determined to be highly likely to have an IPF diagnosis based on database rules developed from the pilot qualitative study
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Idiopathic Pulmonary Fibrosis (IPF) patients
• Estimated number of subjects:
  2223

Study design details

• Main study objective:
  To explore the real life clinical pathways and feasibility of characterising pathways towards diagnosis of idiopathic pulmonary fibrosis (IPF) using real-world data.
• Outcomes:
  Patient pathways to IPF diagnosis will be characterised from the period starting at the first symptoms and clinical features suggestive of IPF up to IPF diagnosis date using pathway features. Pathway features will be defined and standardised after an exploratory, qualitative review of a subgroup of patients, followed by a quantitative summary of pathways for IPF diagnoses. The different pathways characterised will be compared to the ideal pathway that highlights the blocks and red flags to reduce the time to IPF diagnosis in existing and potential IPF patients. Blocks will be identified and quantified as delays (additional time spent) in the pathway due to the blocks. Red flags are features, signs and symptoms in a patient that indicate development of IPF.
• Data analysis plan:
  Data will be analysed in two stages:1) An exploratory, qualitative review in a subset of the full study population using: a. Read codes and free text in medical records by primary care clinicians recorded in OPCRD, andb. Secondary and tertiary care referral data, including anonymised, scanned clinic letters from specialists and free text, from OPC’s review of in-practice data 2) A quantitative, descriptive summary of the full study population using Read codes and free text in OPCRD only.For the qualitative review, a database algorithm will be developed by compiling code lists for read codes and words list associated with identification of first symptoms and clinical features suggestive of IPF. For the quantitative summary, data will be extracted for variables defined by the code and word lists. For continuous variables, mean, SD, median, inter-quartile range, minimum and maximum will be reported. For categorical variables, frequencies and percentages will be reported.