Effect of the FDA Safety and Innovation Act on racial and gender diversity in neurosurgical device trials.

OBJECTIVE: The US FDA uses evidence from clinical trials in its determination of safety and utility. However, these trials have often suffered from limited external validity and generalizability due to unrepresentative study populations with respect to clinical patient demographics. Section 907 of the FDA Safety and Innovation Act (FDASIA) of 2012 attempted to address this issue by mandating the reporting of certain study demographics in new device applications. However, no study has been performed on its effectiveness in the participant diversity of neurosurgical device trials. METHODS: The FDA premarket approval (PMA) online database was queried for all original neurosurgical device submissions from January 1, 2006, to December 31, 2019. Endpoints of the study included racial and gender demographics of reported effectiveness trials, which were summated for each submission. Chi-square tests were performed on both endpoints for before and after years of FDASIA passage and implementation. RESULTS: A total of 33 device approvals were analyzed, with 14 occurring before SIA implementation and 19 after. Most trials (96.97%) reported gender to the FDA, while 66.67% reported race and 63.64% reported ethnicity. Gender breakdown did not change significantly post-SIA (53.30% female, p = 0.884). Racial breakdown was significantly different from the 2010 US Census for all races (p < 0.001) both pre- and post-SIA. Only Native American race was significantly different in terms of representation post-SIA, increasing from 0% to 0.63% (p = 0.0187). There was no significant change in ethnicity. CONCLUSIONS: The FDASIA, as currently written, does not appear to have had a significant impact on the racial or gender diversity of neurosurgical device clinical trial populations. This may be due to the noncompulsory nature of its guidance, or a lack of more stringent regulation on the composition of clinical trials themselves.

Revision Discectomy with or without Fusion for the Treatment of Recurrent Lumbar Disc Herniation: A Nationwide Analysis of Risk Profiles and Short-Term Outcomes.

OBJECTIVE: We compared the demographics, risk factors, and complications for adult patients with recurrent lumbar disc herniation (RLDH) undergoing revision discectomy with or without concurrent fusion. METHODS: The American College of Surgeons National Surgical Quality Improvement Program database was used to identify patients who had undergone revision discectomy with or without simultaneous fusion. The demographic variables and various peri- and postoperative complications were compared between these 2 patient groups. RESULTS: A total of 6901 discectomy patients were included in the present study, of whom 2996 (43.4%) had undergone revision discectomy with fusion and 3905 (56.6%) had undergone revision discectomy alone. The revision discectomy with fusion group was significantly more likely to be older, female, and White or Black and to have a higher average body mass index than was the revision discectomy alone group. The discectomy with fusion group had longer hospital lengths of stay and was more likely to have a diagnosis of hypertension, insulin-dependent and non-insulin-dependent diabetes, and chronic obstructive pulmonary disease. In addition, the patients who had undergone discectomy with fusion were significantly more likely to develop pneumonia, require ventilation for >48 hours, require a blood transfusion, and to develop urinary tract infection, myocardial infarction, deep vein thrombosis, or pulmonary embolism compared with the patients who had undergone revision discectomy only. CONCLUSIONS: Our findings reveal that older patients with more comorbidities were more likely to undergo revision discectomy with fusion. Also, this surgical group experienced more adverse events after their procedure compared with the revision discectomy only group.

Correlates of Google Search Rankings for Spine Surgeons: An Analysis of Academic Pedigree, Social Media Presence, and Patient Ratings.

STUDY DESIGN: Prospective observational study. OBJECTIVE: The objective of this study is to identify correlates of search ranking among academic pedigree, online ratings, and social media following. SUMMARY OF BACKGROUND DATA: Patients increasingly rely on online search in selecting healthcare providers. When choosing a spine surgeon, patients typically value surgical skill and experience as well as demeanor/bedside manner. It is unclear whether current search engine ranking algorithms reflect these preferences. METHODS: A Google.com search for the top 25 spine surgeon websites by search ranking was conducted for each of the largest 25 American cities. Resulting websites were then perused for academic pedigree, experience, and practice characteristics. Surgeons' research output and impact were then quantified via number of publications and H-index. Online ratings and followers in various social media outlets were also noted. These variables were assessed as possible correlates of search ranking via linear regression and multivariate analyses of variance. RESULTS: A total of 625 surgeons were included. Three categorical variables were identified as significant correlates of higher mean Google search ranking-orthopedics (vs. neurosurgery) as a surgical specialty (P = 0.023), board certification (P = 0.024), and graduation from a top 40 residency program (P = 0.046). Although the majority of the identified surgeons received an allopathic medical education, there was no significant difference in the mean rank of surgeons who had an MD versus DO medical degree (P = 0.530). Additionally, none of the continuous variables collected, including years in practice (P = 0.947), publications (P = 0.527), H-index (P = 0.278), social media following such as on Facebook (P = 0.105), or online ratings such as on Healthgrades (P = 0.080), were significant correlates of Google search ranking. CONCLUSIONS: Google search rankings do not always align with patient preferences, currently promoting orthopedic over neurosurgical specialists, graduation from top residency programs, and board certification, while largely ignoring academic pedigree, research, social media presence, and online ratings. LEVEL OF EVIDENCE: 3.