Outdated Frameworks, Missed Opportunities: A Call for Establishing Classification Criteria for Patients with...

Area of Science:

• Pulmonary Medicine
• Rheumatology
• Clinical Research Methodology

Background:

• Sarcoidosis research is hindered by inconsistent definitions and entry criteria, leading to heterogeneous clinical trial data.
• Lack of standardized classification criteria prevents comparison, replication, and generalization of study outcomes.
• Existing diagnostic criteria are patient-specific, while classification criteria are needed for research to define homogeneous populations.

Purpose of the Study:

• To highlight the urgent need for definite classification criteria for sarcoidosis.
• To emphasize how the absence of classification criteria hampers the interpretation of study outcomes and the development of novel therapies.
• To advocate for defining sarcoidosis based on its characteristics rather than exclusion.

Main Methods:

• Review of existing classification criteria in rheumatology and pulmonary diseases (e.g., lupus, SSc, PAH, asthma, COPD).
• Analysis of the impact of inconsistent definitions on sarcoidosis clinical trial data.
• Conceptualization of sarcoidosis as distinct patient populations requiring unification.

Main Results:

• Sarcoidosis currently lacks established classification criteria, unlike other complex diseases.
• Inconsistent diagnostic and entry criteria result in non-comparable and non-generalizable clinical trial data.
• The heterogeneity of sarcoidosis patient populations necessitates the development of unifying classification criteria.

Conclusions:

• Definite classification criteria are essential for advancing sarcoidosis research and therapy development.
• Establishing classification criteria will enable the definition of homogeneous patient groups for more reliable clinical trials.
• Moving beyond diagnosis of exclusion requires defining sarcoidosis by its intrinsic features through robust classification.