Status: Finalised
First registered on:
19/09/2017
Last updated on:
20/06/2019
1. Study identification
EU PAS Register NumberEUPAS20994
Official titleCharacterising Patient Pathways to the Diagnosis of Idiopathic Pulmonary Fibrosis: Real World Data Study
Study title acronym
Study typeObservational study
Brief description of the studyAn exploratory historical UK database study characterising patient pathways to diagnosis of IPF, identifying and quantifying blocks and red flags through primary, secondary, and tertiary care settings.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Department/Research groupObservational and Pragmatic Research Institute Pte Ltd
Organisation/affiliationOPRI Pte Ltd
Details of (Primary) lead investigator
Title Professor
Last name Price
First name David
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
National study
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed28/06/201728/06/2017
Start date of data collection01/06/201807/07/2018
Start date of data analysis
Date of interim report, if expected
Date of final study report31/08/201828/08/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesRoche100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Price
First name David
Address line 160 Paya Lebar Road, Paya Lebar Square
Address line 2Level 5, Unit 33 & 34
Address line 3
CitySingapore
Postcode409051
CountrySingapore
Phone number (incl. country code)44-2081-233923
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Ms
Last name Chaudhry
First name Isha
Address line 160 Paya Lebar Road, Paya Lebar Square
Address line 2Level 5, Unit 33 & 34
Address line 3
CitySingapore
Postcode409051
CountrySingapore
Phone number (incl. country code)65-68029724
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)Yes
Idiopathic pulmonary fibrosis
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects2223
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Sources of data
Prescription event monitoring
Routine primary care electronic patient registry
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Primary scope : Disease epidemiology
12. Main objective(s)
What is the main objective of the study?
To explore the real life clinical pathways and feasibility of characterising pathways towards diagnosis of idiopathic pulmonary fibrosis (IPF) using real-world data.
Are there primary outcomes?Yes
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.
Are there secondary outcomes?Yes
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.
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
Patients' electronic records will be investigated (retrospectively) from time of their first symptoms and clinical features (as an adult) suggestive of IPF up to index date (defined as the date of first IPF diagnoses).
15. Data analysis plan
Please provide a brief summary of the analysis method
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; and
b. 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.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
