Goncalves, Sandy

Abstract Introduction: Underrepresented communities experience a lack in research participation due to multifaceted barriers including historical research mistrust, language barriers, transportation inaccessibility, and other social determinants of health. The disproportionate representation in racial, ethnic, and medically underserved communities furthers the gap in health disparities and treatment outcomes. For this reason, the Mayo Clinic Community Research Registry (CoRR) was developed in 2022 to specifically create a registry of underrepresented communities and connect them to research studies. Methodology: Mayo Clinic CoRR utilizes a community based participatory research (CBPR) approach involving bidirectional engagement with community participants, partnership with community stakeholders and leaders, dissemination of clinical trial information, and use of evidence-based education materials for community outreach. CoRR community partnerships include fraternities, sororities, churches, the American Legion, local physicians, pharmacies, clinics, and health fair events. Through questionnaires, study participants indicate the level of research participation they are comfortable with and are matched to research studies based on their individualized responses. New Unpublished Data: As of early June 2023, CoRR has 270 participants enrolled in the registry with 94% of participants being Black and 6% Hispanic. Average age of the participants is 63 years and includes 63% female and 37 % male. As community input is vital to its development, Mayo Clinic CoRR has partnered with a community advisory board for ongoing discussion of study procedures and recruitment initiatives. This feedback has resulted in over 25 protocol modifications from bidirectional community input and engagement with the study to tailor it to community needs. Revisions include modification of inclusion and exclusion criteria to allow interested, low literacy participants to join, offering written and online platforms for participation in Somali, French, and Creole languages. CoRR adaptations have also implemented a community newsletter to visually provide updated CoRR information, highlight research studies in which CoRR participants have been included, as well as engage CoRR participants regularly. Future developments for CoRR include the establishment of an ad hoc Committee with registry participants to provide another level of safeguarding for enrolled CoRR participants. Conclusion: Responsivity to the needs of the community is vital for the continued development and success of Mayo Clinic CoRR, which has led to a successful ongoing enrollment of underrepresented communities into research studies. By utilizing targeted CBPR, the CoRR demonstrates a proof of concept in recruiting and retaining participants in hard-to-reach demographics with the goal of reducing health disparities in chronic diseases, including cancer. Citation Format: Emelina Asto-Flores, Chelsea Mir, Sandy Goncalves, Giovanna Moreno Garzon, Nuwanthi Heendeniya, Jennifer Crook, Folakemi Odedina. Increasing involvement and accrual in research studies from communities of underrepresented populations through the lens of a community based participatory approach via the Community Research Registry (CoRR) [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr A038.

Currently, large numbers of clinical trials are performed to investigate different forms of experimental therapy for patients suffering from chronic spinal cord injury (SCI). However, for the enrollment process, there are different views on how the time period between injury and interventions should be determined. Herein, we sought to evaluate the impact of time-to-enrollment in chronic SCI clinical trials. A data set comprising 957 clinical studies from clinicalTrials.gov was downloaded and analyzed focusing on the eligibility criteria for post-injury time-to-enrollment. We also aggregated individual patient data from nine clinical trials of regenerative interventions for chronic SCI selected by a systematic literature search from 1990 to 2018. Characteristics of the studies were assessed and compared by dividing into three groups based on time-to-enrollment (group 1 ≤ 12 months, group 2 = 12–23 months and group 3 ≥ 24 months). In ClinicalTrials.gov registry, 445 trials were identified for chronic SCI where 87% (385) were unrestricted in the maximum post-injury time for trial eligibility. From systematic literature search, nine studies and 156 patients (group 1 = 30, group 2 = 55 and group 3 = 71) were included. The range of time-to-enrollment was 0.5 to 321 months in those studies. We also observed various degrees of motor and sensory improvement in between three time-to-enrollment groups. Our results indicate that enrolling wide ranges of time-to-enrollment in a group may present imprecise outcomes. Clinical trial designs should consider appropriate post-injury time frames to evaluate therapeutic benefit.

OBJECTIVE With the revised WHO 2016 classification of brain tumors, there has been increasing interest in imaging biomarkers to predict molecular status and improve the yield of genetic testing for diffuse low-grade gliomas (LGGs). The T2-FLAIR–mismatch sign has been suggested to be a highly specific radiographic marker of isocitrate dehydrogenase ( IDH ) gene mutation and 1p/19q codeletion status in diffuse LGGs. The presence of T2-FLAIR mismatch indicates a T2-hyperintense lesion that is hypointense on FLAIR with the exception of a hyperintense rim. METHODS In accordance with PRISMA guidelines, we performed a systematic review of the Ovid Medline, Embase, Scopus, and Cochrane databases for reports of studies evaluating the diagnostic performance of T2-FLAIR mismatch in predicting the IDH and 1p/19q codeletion status in diffuse LGGs. Results were combined into a 2 × 2 format, and the following diagnostic performance parameters were calculated: sensitivity, specificity, positive predictive value, negative predictive value, and positive (LR+) and negative (LR−) likelihood ratios. In addition, we utilized Bayes theorem to calculate posttest probabilities as a function of known pretest probabilities from previous genome-wide association studies and the calculated LRs. Calculations were performed for 1) IDH mutation with 1p/19q codeletion ( IDHmut-Codel ), 2) IDH mutation without 1p/19q codeletion ( IDHmut-Noncodel ), 3) IDH mutation overall, and 4) 1p/19q codeletion overall. The QUADAS-2 (revised Quality Assessment of Diagnostic Accuracy Studies) tool was utilized for critical appraisal of included studies. RESULTS A total of 4 studies were included, with inclusion of 2 separate cohorts from a study reporting testing and validation (n = 746). From pooled analysis of all cohorts, the following values were obtained for each molecular profile— IDHmut-Codel : sensitivity 30%, specificity 73%, LR+ 1.1, LR− 1.0; IDHmut-Noncodel : sensitivity 33.7%, specificity 98.5%, LR+ 22.5, LR− 0.7; IDH : sensitivity 32%, specificity 100%, LR+ 32.1, LR− 0.7; 1p/19q codeletion: sensitivity 0%, specificity 54%, LR+ 0.01, LR− 1.9. Bayes theorem was used to calculate the following posttest probabilities after a positive and negative result, respectively— IDHmut-Codel : 32.2% and 29.4%; IDHmut-Noncodel : 95% and 40%; IDH : 99.2% and 73.5%; 1p/19q codeletion: 0.4% and 35.1%. CONCLUSIONS The T2-FLAIR–mismatch sign was an insensitive but highly specific marker of IDH mutation and I DHmut-Noncodel profile, although significant exceptions may exist to this finding. Tumors with a positive sign may still be IDHwt or 1p/19q codeleted. These findings support the utility of T2-FLAIR mismatch as an imaging-based biomarker for positive selection of patients with IDH -mutant gliomas.

OBJECTIVETranspsoas lateral interbody fusion is one of the lateral minimally invasive approaches for lumbar spine surgery. Most surgeons insert the interbody cage laterally and then insert pedicle or cortical screw and rod instrumentation posteriorly. However, standalone cages have also been used to avoid posterior instrumentation. To the best of the authors’ knowledge, the literature on comparison of the two approaches is sparse.METHODSThe authors performed a systematic review and meta-analysis of the available literature on transpsoas lateral interbody fusion by an electronic search of the PubMed, EMBASE, and Scopus databases using PRISMA guidelines. They compared patients undergoing transpsoas standalone fusion (TP) with those undergoing transpsoas fusion with posterior instrumentation (TPP).RESULTSA total of 28 studies with 1462 patients were included. Three hundred and seventy-four patients underwent TPP, and 956 patients underwent TP. The mean patient age ranged from 45.7 to 68 years in the TP group, and 50 to 67.7 years in the TPP group. The incidence of reoperation was found to be higher for TP (0.08, 95% confidence interval [CI] 0.04–0.11) compared to TPP (0.03, 95% CI 0.01–0.06; p = 0.057). Similarly, the incidence of cage movement was found to be greater in TP (0.18, 95% CI 0.10–0.26) compared to TPP (0.03, 95% CI 0.00–0.05; p < 0.001). Oswestry Disability Index (ODI) and visual analog scale (VAS) scores and postoperative transient deficits were found to be comparable between the two groups.CONCLUSIONSThese results appear to suggest that addition of posterior instrumentation to transpsoas fusion is associated with decreased reoperations and cage movements. The results of previous systematic reviews and meta-analyses should be reevaluated in light of these results, which seem to suggest that higher reoperation and subsidence rates may be due to the use of the standalone technique.

Study Design. Systematic review and meta-analysis. Objective. To compare postoperative surgical, radiographic, and patient-reported outcomes following anterior cervical discectomy and fusion (ACDF) with and without plate fixation. Summary of Background Data. ACDF has evolved significantly over the years, including the placement of an anterior plate construct. Although promoting bony osseo-integration at the fusion site, there are a number of plate-related complications that can arise. The non-plating approach is less invasive, however, greater rates of cage subsidence have been associated with this model. Methods. We performed an electronic literature search for human studies that directly compared ACDF with and without anterior plate fixation. Outcomes of interest comprised of postoperative dysphagia, fusion success, and cage subsidence as well as patient reported outcomes, including the Neck Disability Index (NDI) scores and Visual Analog Scale (VAS) for both neck and arm pain. Results. A total of 15 studies (12 observational and 3 randomized controlled trials) and 893 patients (57% males) were included. Overall, ACDF with plate fixation was associated with significantly higher vertebral fusion rates (odds ratio [OR] 1.98; 95% confidence interval [CI] 1.16–3.37), lower subsidence rates (odds ratio [OR] 0.31, 95% CI 0.18–0.52), and more favorable VAS-neck pain scores at last follow-up (mean difference [MD] 0.59, 95% CI −0.78 to −0.41). Conversely, ACDF procedures without plate fixation had marginally better long-term VAS-arm pain scores (mean difference [MD] 0.2, 95% CI 0.04–0.36). No difference was found with regards to dysphagia (OR 1.21, 95% CI, 0.57–2.56) and NDI (MD 0.06, 95% C.I −0.54 to 0.42). Conclusion. Available evidence, although limited, suggests superior surgical outcomes in ACDF procedures with anterior plate fixation (increased fusion, decreased subsidence) and slightly better VAS-neck pain scores at last follow-up. Future longitudinal, multicenter randomized controlled trials should be completed to validate any associations found in this study. Level of Evidence: 3