Race and ethnic representation among clinical trials for diabetic retinopathy and diabetic macular edema within the United States: A review

Sanjiv, Nayan; Osathanugrah, Pawarissara; Harrell, Michael; Siegel, Nicole H.; Ness, Steven; Chen, Xuejing; Cabral, Howard; Mahadevan, Subramanian

doi:10.1016/j.jnma.2021.12.016

Cited by 5 publications

(6 citation statements)

References 20 publications

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“…This approach echoes the principles outlined in studies emphasizing the importance of participant homogeneity in clinical trials. 13,14 The duration of surgery in our study showed no significant difference between the bisoprolol and placebo groups, indicating that preoperative bisoprolol administration does not affect length of ESS, as was observed in other studies as well. 10,15 Interestingly, estimated blood loss was significantly lower in the bisoprolol group compared to the placebo group.…”

Section: Discussionsupporting

confidence: 80%

Effect of preoperative oral bisoprolol on intraoperative outcomes in endoscopic sinus surgery

Alim,

Islam,

Bhoumik

et al. 2024

Int J Res Med Sci

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Background: Endoscopic sinus surgery (ESS) presents challenges in managing intraoperative bleeding and hemodynamic stability. This study evaluates the efficacy of pre-operative oral bisoprolol in improving surgical conditions and outcomes in ESS. Methods: This study was conducted between March 2021 and June 2022 at the department of anaesthesia, Bangabandhu Sheikh Mujib medical University, Dhaka, Bangladesh. This randomized controlled trial was conducted with 50 participants undergoing elective ESS, divided into bisoprolol and placebo groups. Result: The study involved 50 participants undergoing elective ESS, with 25 in the bisoprolol group and 25 in the placebo group. While demographic characteristics, such as age, weight, height, and gender distribution, showed no statistically significant differences between the groups. The placebo group experienced significantly higher estimated blood loss (421.72 ml vs. 156.24 ml, p<0.001) and postoperative hemoglobin levels (12.88 g/dl vs. 11.07 g/dl, p<0.001) compared to the bisoprolol group. Hemodynamic parameters, particularly heart rate, exhibited significant differences at various time points, with the bisoprolol group maintaining a higher heart rate post-premedication, intra-operatively, and post-operatively (p<0.05 for all). In the assessment of intraoperative bleeding using the Fromme-Boezaart scale, the placebo group demonstrated higher incidences of severe bleeding grades (3 and 4) compared to the bisoprolol group, with these differences being statistically significant (p<0.001). Conclusions: Pre-operative oral bisoprolol in ESS patients significantly reduces intraoperative bleeding and anesthetic requirements while maintaining hemodynamic stability. These findings suggest bisoprolol as a beneficial pre-operative medication in ESS, warranting further research to optimize surgical outcomes.

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Section: Discussionsupporting

confidence: 80%

Effect of preoperative oral bisoprolol on intraoperative outcomes in endoscopic sinus surgery

Alim,

Islam,

Bhoumik

et al. 2024

Int J Res Med Sci

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“…There have been a few recent studies examining the underrepresentation of Black and Hispanic populations in DME and diabetic retinopathy trials. This study joins the call for improved representation but differs in a few key ways . RCT populations in this article were compared to corresponding demographic characteristics as reported in the US Census instead of to treatment databases.…”

Section: Discussionmentioning

confidence: 99%

“…Additional studies to identify recruitment barriers for underrepresented racial and ethnic minority groups will need to be performed, but the literature has already identified some barriers that should be considered in future studies by, for example, increasing racial and ethnic representation among investigators and working to rebuild trust with communities that may be fearful of health care researchers due in part to past institutional health care injustices and systemic racism. Sanjiv et al indicate that involving anthropologists may be helpful in rebuilding critical trust with these communities, aiding researchers in the direct engagement with the perceived needs of marginalized communities to further garner respect and reduce existing disparities. These challenges are not impossible to surmount, but they will need to be purposefully addressed with an integrated approach among health care professionals and the institutions within which they operate.…”

Section: Discussionmentioning

confidence: 99%

Representation of Race and Ethnicity in Randomized Clinical Trials of Diabetic Macular Edema and Retinal Vein Occlusion Compared to 2010 US Census Data

2022

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ImportanceDiverse enrollment and adequate representation of racial and ethnic minority groups in randomized clinical trials (RCTs) are valuable to ensure external validity and applicability of results.ObjectiveTo compare the distribution of race and ethnicity in RCTs of diabetic macular edema (DME) and macular edema from retinal vein occlusion (RVO) to that of US Census data.Design, Setting, and ParticipantsThis was a cross-sectional retrospective analysis comparing racial and ethnic demographic characteristics of US-based RCTs of DME and RVO between 2004 and 2020 with 2010 US Census data. PubMed and ClinicalTrials.gov were searched to screen for completed phase 3 RCTs with published results. Of 169 trials screened, 146 were excluded because they were incomplete, did not report race and ethnicity, or were not based in the US, and 23 trials were included (15 DME and 8 RVO). The number and percentage of American Indian or Alaska Native, Asian, Black, Hispanic, Native Hawaiian or Other Pacific Islander, and White participants was recorded in each RCT. The demographic distribution and proportion was compared to the reported distribution and proportion in the 2010 US Census using the χ2 test.Main Outcomes and MeasuresOverrepresentation, underrepresentation, or representation commensurate with 2010 US Census data in the racial and ethnic populations of RCTs of retinal vascular disease.ResultsIn 23 included RCTs of DME and RVO, there were a total of 38 participants (0.4%) who identified as American Indian or Alaska Native and Native Hawaiian or Other Pacific Islander (groups combined owing to small numbers), 415 Asian participants (4.4%), 904 Black participants (9.6%), 954 Hispanic participants (10.1%), and 7613 White participants (80.4%). By comparison, the 2010 US Census data indicated that 1.1% of the US population self-reported as American Indian or Alaska Native and Native Hawaiian or Other Pacific Islander (groups combined for comparison in this study), 4.8% self-reported as Asian, 12.6% as Black or African American, 16.3% as Hispanic, and 63.7% as White. American Indian or Alaska Native and Hawaiian or Other Pacific Islander participants were underrepresented in 2 trials, neither overrepresented nor underrepresented in 20, and not overrepresented in any of the included trials. Asian participants were underrepresented in 10 trials, overrepresented in 4, and neither overrepresented nor underrepresented in 8. Black participants were underrepresented in 9 trials, overrepresented in 2, and neither overrepresented nor underrepresented in 11. Hispanic participants were underrepresented in 15 trials, overrepresented in 2, and neither overrepresented nor underrepresented in 5. White participants were underrepresented in 2 trials, overrepresented in 14, and neither overrepresented nor underrepresented in 7. The χ2 values comparing RCT demographic distribution to US 2010 Census data were significantly different in 22 of 23 included RCTs.Conclusions and RelevanceThe findings in this study indicated a discrepancy between racial and ethnic demographic data in RCTs of DME and RVO and the US population according to the 2010 Census. White study participants were most frequently overrepresented, and Hispanic study participants were most frequently underrepresented. These findings support the need for more efforts to recruit underrepresented racial and ethnic minorities to improve external validity in trial findings.

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“…Multiple prior studies have reported that Black patients are meaningfully underrepresented in clinical trials, even when other minority races are adequately represented [ 16 ]. Black patients have experienced a threefold disparity in representation in DME trials funded by the National Institute of Health and more than a fourfold disparity in representation in DME trials funded by the pharmaceutical industry or other federal US organizations [ 39 ]. Historically, this discrepancy can be explained in part by patient hesitancy to participate in clinical trials due to a lower level of trust in medical institutions and poorer access to healthcare [ 40 , 41 ].…”

Section: Discussionmentioning

confidence: 99%

Demographic and Socioeconomic Factors in Prospective Retina-Focused Clinical Trial Screening and Enrollment

Cao

Patel

Wong

et al. 2023

JPM

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Historically marginalized populations are disproportionately affected by many diseases that commonly affect the retina, yet they have been traditionally underrepresented in prospective clinical trials. This study explores whether this disparity affects the clinical trial enrollment process in the retina field and aims to inform future trial recruitment and enrollment. Age, gender, race, ethnicity, preferred language, insurance status, social security number (SSN) status, and median household income (estimated using street address and zip code) for patients referred to at least one prospective, retina-focused clinical trial at a large, urban, retina-based practice were retrospectively extracted using electronic medical records. Data were collected for the 12-month period from 1 January 2022, through 31 December 2022. Recruitment status was categorized as Enrolled, Declined, Communication (defined as patients who were not contacted, were contacted with no response, were waiting for a follow-up, or were scheduled for screening following a clinical trial referral.), and Did Not Qualify (DNQ). Univariable and multivariable analyses were used to determine significant relationships between the Enrolled and Declined groups. Among the 1477 patients, the mean age was 68.5 years old, 647 (43.9%) were male, 900 (61.7%) were White, 139 (9.5%) were Black, and 275 (18.7%) were Hispanic. The distribution of recruitment status was: 635 (43.0%) Enrolled, 232 (15.7%) Declined, 290 (19.6%) Communication, and 320 (21.7%) DNQ. In comparing socioeconomic factors between the Enrolled and Declined groups, significant odds ratios were observed for age (p < 0.02, odds ratio (OR) = 0.98, 95% confidence interval (CI) [0.97, 1.00]), and between patients who preferred English versus Spanish (p = 0.004, OR = 0.35, 95% CI [0.17, 0.72]. Significant differences between the Enrolled and Declined groups were also observed for age (p < 0.05), ethnicity (p = 0.01), preferred language (p < 0.05), insurance status (p = 0.001), and SSN status (p < 0.001). These factors may contribute to patient participation in retina-focused clinical trials. An awareness of these demographic and socioeconomic disparities may be valuable to consider when attempting to make clinical trial enrollment an equitable process for all patients, and strategies may be useful to help address these challenges.

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Race and ethnic representation among clinical trials for diabetic retinopathy and diabetic macular edema within the United States: A review

Cited by 5 publications

References 20 publications

Effect of preoperative oral bisoprolol on intraoperative outcomes in endoscopic sinus surgery

Effect of preoperative oral bisoprolol on intraoperative outcomes in endoscopic sinus surgery

Representation of Race and Ethnicity in Randomized Clinical Trials of Diabetic Macular Edema and Retinal Vein Occlusion Compared to 2010 US Census Data

Demographic and Socioeconomic Factors in Prospective Retina-Focused Clinical Trial Screening and Enrollment

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