Patient-Reported Outcome Measures in Endonasal Skull Base Surgery (PROMESS)—Prospective Multicenter Validation Study

Introduction: Pituitary adenomas are common, benign brain tumors that 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 subdomains. This study aims to (1) validate the POS nationally in the UK and Ireland, and (2) explore factors that 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 rhinorrhea), surgical outcomes (e.g., gross total resection), or endocrine outcomes (e.g., endocrine remission).

Methods and Analysis: Patient demographics, tumor characteristics, operative details, inpatient outcomes, and 6-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-center pilot at a tertiary neurosurgical unit and a multi-center study across pituitary units in the United Kingdom. Descriptive analysis will be conducted for demographics, tumor 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: Multicenter 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 centers, total participants enrolled, participant demographics, operative details, inpatient outcomes, and outpatient outcomes.

Publication History

Article published online:
07 February 2025