Prospective validation of a patient-reported nasal quality-of-life tool for endonasal skull base surgery: The Anterior Skull Base Nasal Inventory-12.

OBJECT: Patient-reported quality-of-life (QOL) end points are becoming increasingly important health care metrics. To date, no nasal morbidity instrument specifically designed for patients undergoing endonasal skull base surgery has been developed. In this study, the authors describe the development and validation of a site-specific nasal morbidity instrument to assess patient-reported rhinological outcomes following endonasal skull base surgery. METHODS: Eligible patients included those with planned endonasal transsphenoidal surgery for sellar pathology identified in outpatient neurosurgical clinics of 3 skull base centers from October 2011 to July 2012. An initial 23-question pool was developed by subject matter experts, review of the literature, and from the results of a previous validation study to assess for common rhinological complaints. Symptoms were ranked by patients from "No Problem" to "Severe Problem" on a 6-point Likert scale. Exploratory factor analysis, change scores, and importance rank were calculated to define the final instrument consisting of 12 items (The Anterior Skull Base Nasal Inventory-12, or ASK Nasal-12). Psychometric validation of the final instrument was performed using standard statistical techniques. RESULTS: One hundred four patients enrolled in the study. All patients completed the preoperative survey and 100 patients (96%) completed the survey 2-4 weeks after surgery. Internal consistency of the final instrument was 0.88. Concurrent validity measures demonstrated a strong correlation between overall nasal functioning and total scores (p < 0.001). Test-retest reliability measures demonstrated a significant intraclass correlation between responses (p < 0.001). Effect size as calculated by standardized response mean suggested a large effect (0.84). Discriminant validity calculations demonstrated that the instrument was able to discriminate between preoperative and postoperative patients (p < 0.001). CONCLUSIONS: This prospective study demonstrates that the ASK Nasal-12 is a validated, site-specific, unidimensional rhinological outcomes tool sensitive to clinical change. It can be used in conjunction with multidimensional QOL instruments to assess patient-reported nasal perceptions in endonasal skull base surgery. This instrument is being used as a primary outcome measure in an ongoing multicenter nasal morbidity study. Clinical trial registration no.: NCT01504399 (ClinicalTrials.gov).

Outcome predictors and spectrum of treatment eligibility with prospective protocolized management of intracerebral hemorrhage.

OBJECTIVE: Risk predictors, spectrum of treatment eligibility, and range of expected outcomes have not been validated in consecutive series including all cases of intracerebral hemorrhage (ICH) subjected to a prospective management protocol based on current guidelines. METHODS: Eighty-six cases of ICH were prospectively identified in conjunction with screening for a clinical trial during an 18-month period. All patients were subjected to protocolized management based on published "best practice" guidelines for ICH. Medical records were reviewed by trained researchers, and outcomes were assessed at various time points including latest follow-up (range, 0-24 months; mean, 3.97 months). Initial assessment parameters, treatment eligibility, and outcomes were based on standardized criteria. RESULTS: In accordance with past literature, mortality and functional outcomes were significantly worse in older patients, those with a larger ICH volume, and worse Glasgow Coma Scale scores, in univariate and multivariate models. The presence and severity of associated intraventricular hemorrhage also correlated with mortality and outcome. Significantly lower mortality (P = 0.024) and better functional outcomes (P = 0.018) were achieved at 30 days in patients with an ICH volume of less than 30 cm in this series than in previously published community-based historical controls without protocolized care. A tight correspondence between treatment eligibility and treatment administered was found. CONCLUSION: Previous estimates of poorer outcome in patients with ICH might not apply to contemporary management protocols, especially in patients with a smaller ICH volume. Outcome ranges in various risk categories and modeling of treatment eligibility will help project more realistic prognostication and assist with the design of future trials.