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Observational Study
. 2023 Feb 11;23(1):64.
doi: 10.1186/s12890-023-02333-7.

Investigating significant health trends in progressive fibrosing interstitial lung disease (INSIGHTS-ILD): rationale, aims and design of a nationwide prospective registry

Juergen Behr  1 , Francesco Bonella  2 , Andreas Günther  3 , Dirk Koschel  4 , Antje Prasse  5 , David Pittrow  6 , Jens Klotsche  7 , Michael Kreuter  8   9 ; INSIGHTS-ILD Study Group
Collaborators, Affiliations
Observational Study

Investigating significant health trends in progressive fibrosing interstitial lung disease (INSIGHTS-ILD): rationale, aims and design of a nationwide prospective registry

Juergen Behr et al. BMC Pulm Med. .

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.

Keywords: Ambulatory setting; Health care; Interstitial lung disease; Longitudinal; Lung fibrosis; Observational trial; Outcomes; Quality of life.

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Conflict of interest statement

JB: Jürgen Behr received honoraria for consulting and lectures from Actelion, Astra-Zeneca, Biogen, BMS, Boehringer-Ingelheim, Ferrer, Galapagos, Novartis, Roche, Sanofi-Genzyme. The INSIGHTS-ILD study is funded by Boehringer Ingelheim, Germany. FB: grants to his institution by Boehringer Ingelheim and Roche, fees for consulting by Savara, Roche, Sanofi and Boehringer Ingelheim. DP: received consultancy fees from Amgen, Aspen, Biogen, Daiichi Sankyo, Sanofi-Genzyme, Sandoz/Novartis and MSD. AP: none. JK: none. DK: fees for consulting by Roche and Boehringer Ingelheim. MK: grants to his institution by Boehringer Ingelheim and Roche, fees for consulting by Roche, Galapagos and Boehringer Ingelheim.

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