Healthcare resource utilization among patients diagnosed with Systemic Sclerosis-associated Interstitial Lung Disease in the United Kingdom: An observational study using the Clinical Practice Research Datalink - INTERSTELLAR

Study type
Protocol
Date of Approval
Study reference ID
16_262
Lay Summary

Systemic sclerosis (SSc) is a group of rare diseases that involve the hardening and tightening of the skin and connective tissues - the fibers that provide the framework and support for your body. In some people, SSc affects only the skin. But in many people, SSc also harms structures beyond the skin - such as blood vessels, internal organs and the digestive tract. Signs and symptoms vary, depending on which structures are affected. SSc is associated with conditions such as interstitial lung disease, which is an inflammation of the lungs that causes severe scarring, with the highest rates of death among patients with both SSc and interstitial lung disease (SSc-ILD). Currently there are no disease-specific drug treatments for SSc-ILD. Developing treatments to effectively manage patients with SSc-ILD may lead to improvements in overall health outcomes among these patients. This study aims to assess the amount of interactions patients have with healthcare professionals and how much these interactions may costs among patients with SSc-ILD. The results from this study will help to describe the clinical and financial burden of SSc-ILD in real-world settings and demonstrate the existing unmet needs of patients with SSc-ILD.

Technical Summary

Published research suggests that the burden of Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD), both clinical and economic, is substantial; however, evidence regarding characteristics of patients with SSc-ILD is limited, as are assessments of health care resource utilisation and costs incurred during management of SSc-ILD. This study aims to assess healthcare resource utilisation and costs among patients with SSc-ILD. Demographics, comorbidities and medication history will be described for the cohort of SSc patients and the sub-cohorts of ILD and for patients with other organ involvement (OOI). Health care resource utilisation and costs will be summarised for the overall study sample and for the SSc-ILD SSc-OOI sub-cohorts stratified by service setting, cause of use (SSc/non-SSc related), and by treatment type. We will also conduct multivariable regression analyses using backwards selection methods to examine predictors of adjusted total all-cause and SSc-related health care costs. The results derived from this non-interventional study based on existing data will help quantify the clinical and economic burden of SSc-ILD in real-world settings and demonstrate the existing unmet needs among patients with SSc-ILD. Furthermore, results may be included as inputs in future economic models developed for evaluating the cost-effectiveness of SSc-ILD treatment options.

Health Outcomes to be Measured

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Collaborators

Chris D Poole - Chief Investigator - Digital Health Labs Limited
Alicia Gayle - Corresponding Applicant - Imperial College London
Christina Raabe - Collaborator - Boehringer-Ingelheim International GmbH
James Richardson - Collaborator - Boehringer-Ingelheim - UK
Margarida Alves - Collaborator - Boehringer-Ingelheim International GmbH
Nils Schoof - Collaborator - Boehringer-Ingelheim Germany
Prithwiraj Das - Collaborator - Boehringer-Ingelheim - UK
Toby Maher - Collaborator - Royal Brompton Hospital

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Admitted Patient Care;HES Outpatient