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RESEARCH PRODUCT

Minimal clinically important difference for asthma endpoints: an expert consensus report

Marcello Di PaoloMatteo BoniniMatteo BoniniGianenrico SennaIlaria BaiardiniGiorgio Walter CanonicaElisiana CarpagnanoManlio MilaneseStefano Del GiaccoMarco ContoliIlaria MenichiniEnrico HefflerDiego BagnascoFulvio BraidoNicola ScichiloneMarco CaminatiAngelo CorsicoCarlo Lombardi

subject

Asthma asthma management minimal clinically important difference end-pointsPulmonary and Respiratory Medicinemedicine.medical_specialtyConsensusDelphi TechniqueEndpoint DeterminationBronchoconstrictionMEDLINEDelphi methodSocio-culturaleSettore MED/10 - MALATTIE DELL'APPARATO RESPIRATORIOminimal clinically important difference; asthma; lung function; biomarkersMCID03 medical and health sciences0302 clinical medicinePredictive Value of TestsmedicineHumansAnti-Asthmatic Agents030212 general & internal medicineDisease management (health)Intensive care medicineLungAsthmalcsh:RC705-779business.industryMinimal clinically important differenceminimal clinically important differenceExpert consensusend-pointslcsh:Diseases of the respiratory systemmedicine.diseaseMCID asthmaAsthmaTreatment Outcome030228 respiratory systemPredictive value of testsEndpoint DeterminationInflammation MediatorsSymptom AssessmentbusinessBiomarkersasthma management

description

Minimal clinically important difference (MCID) can be defined as the smallest change or difference in an outcome measure that is perceived as beneficial and would lead to a change in the patient's medical management.The aim of the current expert consensus report is to provide a “state-of-the-art” review of the currently available literature evidence about MCID for end-points to monitor asthma control, in order to facilitate optimal disease management and identify unmet needs in the field to guide future research.A series of MCID cut-offs are currently available in literature and validated among populations of asthmatic patients, with most of the evidence focusing on outcomes as patient reported outcomes, lung function and exercise tolerance. On the contrary, only scant and partial data are available for inflammatory biomarkers. These clearly represent the most interesting target for future development in diagnosis and clinical management of asthma, particularly in view of the several biologic drugs in the pipeline, for which regulatory agencies will soon require personalised proof of efficacy and treatment response predictors.

https://doi.org/10.1183/16000617.0137-2019