Development of a Core Outcome Set for Intervention Studies in Adults With Laryngotracheal Stenosis

Adult acquired laryngotracheal stenosis (LTS) is a chronic condition with heterogeneous treatment options and a significant symptom burden. Synthesis of data across research studies to guide clinical decision-making is challenging due to inconsistent outcome selection and use of unvalidated measures. Our objective was to establish a core outcome set (COS) for studies of LTS interventions in adults.

We conducted a two-round modified e-Delphi study. We reviewed published systematic reviews and qualitative studies to inform the inclusion of 42 outcomes in the first e-Delphi round, with 10 additional outcomes added by participants for the second voting round. The international expert panel included clinicians, researchers, and people living with LTS. We held two consensus meetings and a final voting round.

The first e-Delphi round involved 1067 participants from multiple stakeholder groups, with 575 participants voting in the second. Seventeen participants participated in the consensus meetings. The final COS included seven outcomes: (1) Level of breathlessness, (2) Ability to generate audible voice, (3) Ability to manage/clear mucus, (4) Ability to eat and drink, (5) Health-related quality of life, (6) Emotional and mental health symptoms, and (7) Frequency of treatment.

By using a rigorous Delphi process informed by multiple stakeholder groups, we gained consensus on seven core outcomes for inclusion in future research relating to LTS. Use of this COS will standardize outcomes measured in future research studies, ensuring they are comparable. Future work is required to identify the best way to measure these outcomes to fully operationalize this COS.

Level V.