2025 Poster Presentations
P237: PATIENT-REPORTED OUTCOME MEASURES IN ENDONASAL SKULL BASE SURGERY (PROMESS)— PROSPECTIVE MULTI CENTRE VALIDATION STUDY
Joachim Starup-Hansen, BMBS1; John G Hanrahan, MBBS, BSc1; Danyal Z Khan, MRCS1; Simon C Williams, MRCS, BMedSci, MBChB2; Jonathan Funnell, MRCS3; Chan Hee Koh, MRCS1; George E Richardson, MBChB, MRes1; Stephanie E Baldeweg, FRCP4; Hani J Marcus, PhD, FRCS1; Promess Consortium5; 1The National Hospital for Neurology and Neurosurgery, London, UK.; 2The Royal London Hospital, London, UK; 3Kings College Hospital, London, UK; 4University College London Hospitals NHS Foundation Trust,; 5Promess Consortium
Introduction: Pituitary adenomas are common, benign brain tumours which can significantly affect quality of life (QoL) through ophthalmic or endocrine sequelae. Surgical intervention, primarily via the transsphenoidal approach, is the primary treatment for large non-functioning and a subset of functioning adenomas. Currently, there is no dedicated Patient Reported Outcome Measure to measure the change in QoL of pituitary patients undergoing surgery. To address this, we previously developed the Pituitary Outcome Score (POS), a dedicated Patient Reported Outcome Measure for pituitary patients that measures overall QoL as well as ophthalmic, endocrine, and nasal QoL sub-domains. This study aims to 1) validate the POS nationally in the UK and Ireland, and 2) explore factors which may impact changes in POS after pituitary surgery, including operative techniques (e.g. surgical approach or skull base repair methods), inpatient complications (e.g. cerebrospinal fluid rhinorrhoea), surgical outcomes (e.g. gross total resection), or endocrine outcomes (e.g. endocrine remission).
Methods and Analysis: Patient demographics, tumour characteristics, operative details, inpatient outcomes and six month outcomes will be collected. Surveys including the POS, and validated comparator surveys such as Short Form-36, and Global Perceived Effect Scale will be distributed at four time-points to assess the validity, reliability, responsiveness, and interpretability of the POS. This study will be conducted in two parts: a single-centre pilot at a tertiary neurosurgical unit and a multi-centre study across pituitary units in the United Kingdom.
Descriptive analysis will be conducted for demographics, tumour characteristics, operative details, complications, and outcomes. The POS will be evaluated in terms of reliability (including internal consistency and test-retest reliability), and structural and construct validity, inferred by intradomain correlations and correlation to SF-36 respectively. The responsiveness of the POS will be measured through Spearman's correlation coefficient and effect size calculations. Comparative analysis will explore the relationship between the outcomes as measured by QoL scales and operative methods, complications, surgical outcomes and endocrine outcomes. The study hypothesizes that higher QoL scores (POS) are associated with non-extended surgical approaches, less invasive repair methods, the absence of complications, and endocrine remission.
Ethics and Dissemination: The study will be registered as a quality improvement project with the local governance committees of participating units. Ethical considerations include informed consent, data privacy, and the potential impacts of the study on patient care. The primary study’s results will be disseminated through publications in peer-reviewed journals as well as through patient support networks. Secondary aims will be addressed in follow-up publications.
Results and Discussion: Multicentre recruitment will start in October 2024 and thus interim study findings will be shared. Results will include descriptive statistics pertaining to the number of recruited centres, total participants enrolled, participant demographics, operative details, inpatient outcomes and outpatient outcomes.