Establishing comparability between measured outcomes in clinical trials poses a significant obstacle for systematic reviewers. Core outcome sets (COSs) were developed to address this issue. The macular degeneration (MD) COS is designed to standardise outcome measurement across clinical trials for MD. This study investigates the uptake of the MD COS in standardising outcome measurement across clinical trials.

Cross-sectional analysis

We conducted a search on ClinicalTrials.gov to locate MD clinical trials that were registered 5 years prior to COS publication through the search date of 26 June 2023 and obtained a pool of 2152 registered studies. After applying various inclusion and exclusion criteria, we analysed 159 trials. We then analysed the COS uptake using an interrupted time series analysis (ITSA) and performed performed analyses of variance (ANOVAs) and Pearson correlations to evaluate associations between trial characteristics and outcome measurement.

ITSA showed no significant change in uptake following the MD COS (2016): mean percentage of completion of the COS increased by 0.24% per month before publication (p=0.27) and by 0.07% per month after publication (p=0.62), indicating no meaningful post-publication slope change in COS use. For context, visual acuity was most commonly measured, while several patient-reported and disutility domains were infrequently captured.

No discernible patterns in COS usage for MD trials were observed. We recommend further collaboration between regulators and COS developers to help with COS uptake. Additionally, we suggest that further studies analyse adherence to COSs in respect to regulatory recommendations.

There remains little consensus or guidelines for the clinical management of traumatic orbital fractures (OFx). The OFx Registry aims to increase real-world clinical evidence for the treatment of OFx via prospective, multicentre, international data collection. The primary objectives of this observational cohort study are (1) to document current treatment practices for and (2) to assess the outcomes of surgical and non-surgical treatment of orbital floor and/or medial wall fractures.

Approximately 300 adult patients presenting with a displaced OFx in the orbital floor and/or medial wall will be enrolled prospectively over a recruitment period of ~36 months. All eligible patients treated either surgically or non-surgically as per routine standard of care will have follow-up assessments at 6 weeks, 3 months and 6 months post-treatment. Demographic data, injury details, treatment details and outcome measures will be documented in a cloud-based database. Outcome measures include clinical outcomes (eg, diplopia, extraocular motility, and condition of the eyelid, globe and soft tissues), radiological outcomes from collected images, patient-reported outcomes (eg, Diplopia Questionnaire and the newly developed AO Craniomaxillofacial (CMF) Injury Symptom Battery) and complications. A statistical analysis plan will be prepared before final analysis summarising the descriptive statistics to be used for data assessment. Appropriate research questions and statistical tests may be applied additionally, depending on the availability and quality of data collected.

Ethics approval was obtained before patients were enrolled at each participating site. Patient enrolment followed an informed consent process approved by the responsible ethics committee. Peer-reviewed publications are planned to disseminate the study results.

NCT03887988.