The Landscape of Vestibular Schwannoma Microsurgical Resection Clinical Trials: A Scoping Review.

OBJECTIVE

We sought to analyze contemporary clinical trials since 2010 involving vestibular schwannoma (VS) patients undergoing microsurgical resection to characterize the landscape of trial outcomes studied, as well as the representation of recruited participants by sex, race, and ethnicity.

DATABASES REVIEWED: PubMed, Embase, CENTRAL, and Web of Science.

METHODS

Each study's title/abstract and full texts were independently reviewed by 2 study team members. Articles were included if they reported data for both age and sex of VS adult participants undergoing microsurgical resection. Articles were also required to meet the NIH's definition of a clinical trial to be included. Studies before 2010, those with pediatric participants, or those with any participants with neurofibromatosis-related VS or other cerebellopontine angle pathologies were excluded. Categorical variables were reported as raw numbers/percentages. Participation-to-prevalence ratios (PPR) were calculated to assess sex representation compared with the general population.

RESULTS

Fifty-two studies (n=3666 participants) met the inclusion criteria. The mean age of participants was 49.1 years old. Most studies were conducted in Europe (44.2%) or North America (26.9%). Only 9 studies (17.3%) were randomized controlled trials. Common primary outcomes assessed included postoperative outcomes (36.5%) and intraoperative measurements (eg, of auditory nerve function) (28.8%), reporting hearing, vestibular, and facial nerve outcomes. There was good representation of both females and males as compared with the general population with respect to primary outcomes, surgical approach, and study continent (0.8> PPR <1.2). Only one study reported on race/ethnicity.

CONCLUSION

Greater emphasis on geographically diverse and demographically inclusive clinical trials may strengthen evidence produced by VS microsurgery research efforts.