View Study

Status: Finalised First registered on: 14/01/2016

Last updated on: 12/03/2019

1. Study identification

EU PAS Register NumberEUPAS12086

Official titleIDENTIFYING OPPORTUNITIES FOR EARLIER DIAGNOSIS OF IDIOPATHIC PULMONARY FIBROSIS IN ROUTINE CARE IN THE UK: A RETROSPECTIVE CLINICAL COHORT STUDY

Study title acronymOPPORTUNITIES FOR EARLIER IPF DIAGNOSIS

Study typeObservational study

Brief description of the studyIn the UK, all patients who ultimately receive a diagnosis of IPF will have first presented in the primary care setting. Thus by carrying out a historical review of the primary care records for patient in the years preceding their IPF diagnosis, it should be possible to identify common patterns (trends) in healthcare resource utilization (HRU) and identify potential “red flags” to support decision support tools to aid earlier diagnosis. With a view to identifying potential opportunities for earlier referral to specialists and (ultimately) earlier diagnosis of IPF, this study aims to: (i) Evaluate patients’ patterns of HRU in the years preceding their IPF diagnosis. (ii) Characterise the clinical features of patients at the time of their IPF diagnosis.

Was this study requested by a regulator?Don't know

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

Centre to which the investigator belongsOPRI Pte Ltd

Department/Research groupResearch in Real Life Ltd

Organisation/affiliationOPRI Pte Ltd

Website/Homepagewww.rirl.org

Details of (Primary) lead investigator

Title Professor

Last name Luca

First name Richeldi

Is this study being carried out with the collaboration of a research network?

Yes

Respiratory Effectiveness Group (REG)

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 signed29/01/201629/11/2016

Start date of data collection05/02/201610/12/2016

Start date of data analysis

Date of interim report, if expected

Date of final study report28/10/201621/12/2016

4. Sources of funding

Please provide estimates of the percentage of funding by source for this study

Names(s)Approximate % funding

Pharmaceutical companies

Charities

Government body

Research councils

EU funding scheme

OtherRespiratory Effectiveness Group100

5. Contact details for enquiries

Scientific Enquiries

Title Professor

Last name Luca

First name Richeldi

Address line 1National Institute for Health Research

Address line 2Southampton Respiratory Biomedical Research Unit

Address line 3

CitySouthampton

Postcode

CountryUnited Kingdom

Phone number (incl. country code)4401223967582

Alternative phone number

Fax number (incl. country code)

Email address dprice@opri.sg

Public Enquiries

Title Professor

Last name Luca

First name Richeldi

Address line 1National Institute for Health Research

Address line 2Southampton Respiratory Biomedical Research Unit

Address line 3

CitySouthampton

Postcode

CountryUnited Kingdom

Phone number (incl. country code)4401223967582

Alternative phone number

Fax number (incl. country code)

Email address dprice@opri.sg

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?

With a view to identifying potential opportunities for earlier referral to specialists and (ultimately) earlier diagnosis of IPF, this study aims to: (i) Evaluate patients’ patterns of HRU in the years preceding their IPF diagnosis. (ii) Characterise the clinical features of patients at the time of their IPF diagnosis.

Are there primary outcomes?Yes

1. Consultations including lower respiratory (LR) consultations 2. Hospitalisations (in-patient attendances): same day or following 7 days 3. Out patient visits with a code for a LR complaint (same day or following 7 days) 4. Accident & Emergency attendances coded for a LR complaint (same day or following 7 days) 5. Chest X-ray

Are there secondary outcomes?No

13. Study design

What is the design of the study?

Observational, historical database study

14. Follow-up of patients

Will patients be followed up?Not applicable/no follow-up

15. Data analysis plan

Please provide a brief summary of the analysis method

• The analysis will assess changes in HRU over the 25-year period (1990–2015), and in 5-year increments (0–5 years; 6–10 years, 11–15 years, 16–20 years and 21–25 years) • Summary statistics will be used to characterise patients at time of IPF diagnosis: o For variables measured on the interval or ratio scale, summary statistics produced will be: • Sample size (n) • Percentage non missing • Mean • Variance/standard deviation • Range (minimum- maximum) • Median • Inter-quantile range (25th and 75th percentile) o For categorical variable the summary statistics will include: • Sample size (n) • Range • Count and percentage by category (distribution) • Statistically significant results will be defined as p<0.05 and trends as 0.05≤p<0.10. • Suitable tests (e.g. F tests, t tests, χ2 tests) and models (e.g. linear models) will be used, as appropriate, to explore the interaction between different clinical characteristics and features (e.g. year, age) of diagnosis.