Investigating significant health trends in progressive fibrosing interstitial lung disease (INSIGHTS-ILD): rationale, aims and design of a nationwide prospective registry
Research output: Contribution to journal › Research article › Contributed › peer-review
Contributors
- Ludwig Maximilian University of Munich
- University Hospital Essen
- Universities of Giessen and Marburg Lung Center (UGMLC)
- Hannover Medical School (MHH)
- Medical Faculty Carl Gustav Carus
- Heidelberg University
- RKH Hospital Ludwigsburg
- University of Duisburg-Essen
- Institute of Clinical Pharmacology
Abstract
Background: The progressive course of pulmonary fibrosis (PPF) is observed with variable prevalence in different entities of fibrosing interstitial lung disease (fILD). PPF is characterised by worsening respiratory symptoms, declining lung function and increasing extent of fibrosis on high-resolution computer tomography. In Germany, data are limited on the characteristics and management of such patients. Methods/Design: INSIGHTS-ILD is a prospective observational longitudinal registry designed to describe characteristics, management and course of newly diagnosed (incident) and prevalent patients with fILD on the long term. The registry uses a non-probability sampling approach to collect data on characteristics, therapeutic interventions, health-related quality of life and health economic parameters. It is planned to include 900 patients in ambulatory care in about 30 expert sites over three years. The study has been initiated in December 2021, and currently (January 2023) follows 360 patients. Discussion: The registry is expected to provide much-needed data on the characteristics, management, and trajectories of patients fILD in Germany. The start of the study comes at a time when new treatment options are available for PPF. We hypothesize that PPF represents a broad clinical phenotype that is differentially influenced by inflammatory and fibrotic pathomechanisms that need to be treated with anti-inflammatory and/or anti-fibrotic treatment strategies. This registry will allow comparisons with other countries. Gap analyses based on current guidelines for management of these patients will be possible. Trial registration DRKS00027389 (registered on 7.12.2021), BfArM NIS 7562.
Details
Original language | English |
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Article number | 64 |
Pages (from-to) | 1-9 |
Number of pages | 9 |
Journal | BMC pulmonary medicine |
Volume | 23 |
Issue number | 1 |
Publication status | Published - Dec 2023 |
Peer-reviewed | Yes |
External IDs
PubMed | 36774483 |
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Keywords
ASJC Scopus subject areas
Keywords
- Ambulatory setting, Health care, Interstitial lung disease, Longitudinal, Lung fibrosis, Observational trial, Outcomes, Quality of life