Scout - sarcoidosis outcomes taskforce. A systematic review of outcomes to inform the development of a core outcome set for pulmonary sarcoidosis.

BACKGROUND

Clinical trials evaluating different management strategies for pulmonary sarcoidosis may measure different outcomes. This heterogeneity in outcomes can lead to waste in research due to the inability to compare and combine data. Core outcome sets (COS) have the potential to address this issue and here we describe a systematic review of outcomes as the first step in the development of a COS for pulmonary sarcoidosis research.

METHODS

A search of clinical trial registries for phase II, III and IV trials of pulmonary sarcoidosis was undertaken along with a rapid review of the patient perspective literature. Each study was screened for eligibility and outcomes extracted verbatim from the registry entry or publication then reviewed, grouped and categorised using the COMET taxonomy.

RESULTS

36 trial registry entries and 6 studies on patients' perspective of pulmonary sarcoidosis were included reporting 56 and 82 unique outcomes respectively across 23 domains. The most frequently reported outcome domain was "respiratory, thoracic and mediastinal outcomes". However, the patients' perspective literature identified outcomes in the "personal circumstances" and "societal/carer burden" domains that were not reported in any of the included trial registrations.

CONCLUSIONS

Using both clinical trial registry data and published literature on patients' perspective has allowed rapid review of outcomes measured and reported in pulmonary sarcoidosis research. The use of multiple sources has led to the development of a comprehensive list of outcomes that represents the first step in the development of a COS for use in future pulmonary sarcoidosis research.

Informations de copyright

Copyright: © 2021 SARCOIDOSIS VASCULITIS AND DIFFUSE LUNG DISEASES.

Déclaration de conflit d'intérêts

COMET – Core Outcome Measures in Effectiveness Trials; COS - Core Outcome Set; PROM – Patient Reported Outcome MeasureThe datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.NLH, SLG, PRW, RPB, MAJ, NAK, DEV, JCG, DAC have no competing interests. ESB is an employee of Janssen Research and Development, LLC, who has sponsored research studies in Sarcoidosis. EJS is an employee of Insmed Incorporated. MW employee of Janssen Research & Development. HJ is a sarcoidosis patient. TA-H, HN and NS were employed by the funder (The Foundation for Sarcoidosis Research) during the research.This study was funded by the Foundation for Sarcoidosis Research (https://www.stopsarcoidosis.org/). The Funder was an active member of the Study Management Group, they facilitated organization of meetings with the Study Steering Committee, contributed to the study design and reviewed the manuscript.NLH: Conceived and designed the analysis. Performed the search, extracted and categorised outcomes. Drafted the manuscript. SLG: Conceived and designed the analysis. Performed the search, extracted and categorised outcomes. Reviewed and approved the manuscript. PRW: Conceived and designed the analysis. Supervised the project. Reviewed and approved the manuscript. DAC: Contributed to the study design. Contributed to outcome categorisation and data analysis. Reviewed and approved the manuscript. NS, EB, RB, HJ, NK, ES, DV, MW, TA-H, HN, JG: Contributed to the study design. Reviewed and approved the manuscript.