Considerations for Endpoints in Lung Transplant Clinical Trials: An ISHLT Consensus Statement
Evidence level: consensus statement (Delphi); abstract-only
An ISHLT consensus statement gives Delphi-based recommendations on trial endpoints beyond mortality, including CLAD, because unclear endpoints have hindered lung transplant trials.
As of . Primary source: Publisher record via DOI.
Summary
A multidisciplinary ISHLT working group developed consensus recommendations on endpoints beyond mortality for lung transplant trials: primary graft dysfunction, CLAD, acute cellular rejection, antibody-mediated rejection, immunosuppression-related complications, patient-reported outcomes and paediatric considerations. For each endpoint a subgroup reviewed measurement practice, links to clinical benefit and evidence for use in trials, and consensus was reached by a Delphi process of three voting rounds. The document states that clinical trials have been hindered by a lack of clarity on endpoint formulation and significance, and aims to standardise trial design. The specific recommendations were not read.
Details
- doi
- 10.1016/j.healun.2025.09.017
- pmid
- 41400593
- authors
- Greenland JR, Perch M, Halloran K, Levine DJ, Morrell ED, Reed A, Shaver CM, Singer JP, Sweet SC, Vos R, Aryal S, Avdimiretz N, Burrows F, Calabrese D, Calabrese F, Campos S, Combs M, de Perrot M, Dellgren G, Diamond JM, Egan T, Ging P, Glidden DV, Goddard M, Jyothula S, Keller M, Kulkarni H, Kwakkel-van Erp JM, Lama V, Marczin N, Martinu T, Neely ML, Palmer SM, Patterson CM, Pavlisko EN, Pham C, Sanchez M, Schultz HHL, Schwerk N, Shah U, Shashaty M, Singer L, Smith P, Snyder LD, Solomon M, Verleden S, Verplancke V, Zeevi A, Todd JL
- journal
- The Journal of Heart and Lung Transplantation
- year
- 2026
- volume
- 45
- issue
- 2
- pages
- e104-e128
Sources and links
- Publisher record via DOI (primary)
- PubMed 41400593
Related
Links from this record
- relates to: ISHLT 2019 CLAD states: Potential, Possible, Probable and Definite
- authors affiliated with: Toronto Lung Transplant Program (University Health Network)
- authors affiliated with: KU Leuven BREATHE (Laboratory of Respiratory Diseases and Thoracic Surgery)
- coauthor: Lianne Singer
- coauthor: Robin Vos
- coauthor: Tereza Martinu
Linked from (derived)
- author affiliation matches this institution (OpenAlex): St Vincent's Hospital Sydney Heart and Lung Transplant Unit
- author affiliation matches this institution (OpenAlex): UCSF Lung Transplant Program
- author: Lianne Singer
- author: Robin Vos
- author: Tereza Martinu
- evidence: Unclear endpoints and heterogeneous patients hinder CLAD trials
Known gaps in this record
- full text not read (abstract only)
- funding statement and grant numbers
- the specific CLAD endpoint recommendations (full text not read)
- funding
Information resource only. Not medical advice. Not a substitute for the care of the patient's transplant team.