Reporting and Analyzing Demographics in the Journal of Arthroplasty: Are We Making Progress?

Griffin, Sean A.; Magnuson, Justin A.; Sutton, Ryan; Krueger, Chad A.

doi:10.1016/j.arth.2021.09.017

Cited by 11 publications

(8 citation statements)

References 45 publications

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“…These findings imply that rates of sociodemographic reporting may vary amongst RCTs of different orthopedic journals even if they pertain to the same orthopedic domain. Further study of specialtyspecific journals should be performed to increase the power of these results and more accurately identify the rate of reporting and analysis of sociodemographic variables 14 .…”

Section: Discussionmentioning

confidence: 99%

“…All RCTs published in JHS between 2015 and 2021 on human subjects were included. We chose this span of years to reflect continuity with previous orthopedic studies on this topic, which included data from 2015 to their respective dates of publication 14,15 . Longitudinal analysis and previous follow-ups of clinical trials published prior to 2015 were included.…”

Section: Inclusion and Exclusion Criteriamentioning

confidence: 99%

“…Data collection was based on the methodology reported by Griffin et al 14 . A variable was considered reported if the mean or median with or without standard deviation/ quartiles was provided for continuous variables (age, height, weight, BMI) or if a percentage of the study population was provided for categorical variables (sex, race, ethnicity).…”

Section: Data Collectionmentioning

confidence: 99%

“…Racial and ethnic differences in outcomes, decision-making, and other aspects in hand surgery itself further illustrate the health disparities within the field [8][9][10][11][12][13] . Despite racial differences in health outcomes within the orthopedic literature, many randomized controlled trials (RCTs) fail to report race and ethnicity 14,15 . Several reasons for this observation have been postulated, such as the belief that reporting these factors is not clinically relevant and a lack of emphasis to report by medical journals 15 .…”

Section: Introductionmentioning

confidence: 99%

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Low Rates of Reporting and Analyzing Race and Ethnicity in Hand Surgery Randomized Controlled Trials: A Systematic Review

Patankar¹,

Sudah²,

Michel³

et al. 2022

J Orthopedics & Orthopedic Surg

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Purpose: Sociodemographic factors have been shown to influence musculoskeletal health. However, little is known regarding the frequency of reporting and analysis of certain sociodemographic variables (e.g., age, sex, height, weight, body mass index (BMI), race, and ethnicity) in randomized clinical trials (RCTs) pertaining to hand surgery. The purpose of this study was to assess the rate of reporting and analysis of these variables in RCTs published in the Journal of Hand Surgery (JHS). Methods: A systematic review was conducted of RCTs published in JHS between 2015 and 2021. For each study, we determined whether the following sociodemographic variables were reported and/or analyzed: age, sex, height, weight, BMI, race, and ethnicity. Frequencies were reported by year and as a cumulative total. Studies were evaluated using the Cochrane risk-of-bias tool. Results: A total of 45 RCTs met inclusion criteria, with about half (53.3%) originating from the United States. Age (97.8%) and sex (91.1%) were the most frequently reported sociodemographic variables, followed by race (17.8%), BMI (11.1%), and ethnicity (8.9%). Age (17.8%) was the most frequently analyzed variable, followed by sex (13.3%), and race (4.4%); the remaining variables were not analyzed in any study. Conclusions: While age and sex are reported at a high rate, only about 1 in 4 RCTs published in JHS report either race or ethnicity. All sociodemographic variables were infrequently included as part of statistical analysis. The significance of these findings should be recognized and used to interpret and enhance the methodology of future RCTs.

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Section: Discussionmentioning

confidence: 99%

Section: Inclusion and Exclusion Criteriamentioning

confidence: 99%

Section: Data Collectionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Low Rates of Reporting and Analyzing Race and Ethnicity in Hand Surgery Randomized Controlled Trials: A Systematic Review

Patankar¹,

Sudah²,

Michel³

et al. 2022

J Orthopedics & Orthopedic Surg

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“…Although only 49% and 37% of included FDA trials reported race and ethnicity data, this is still better than rates reported by other orthopaedic randomized control trials. 25,26 Paul et al noted only 7.3% of orthopaedic surgery randomized control trials reported race and even fewer (3.1%) reported ethnicity. 25 Reporting of race and ethnicity is important to continue unmasking existing health inequalities and disparities that may hinder certain communities from medical device trial participation, which ultimately ensures adequate generalizability of trials.…”

Section: Discussionmentioning

confidence: 99%

Diversity in Orthopaedic Surgery Medical Device Clinical Trials: An Analysis of the Food and Drug Administration Safety and Innovation Act

Issa

Lambrechts

Lin

et al. 2022

J Am Acad Orthop Surg

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Introduction: Demographic factors contribute markedly to orthopaedic surgery outcomes. However, women and minorities have been historically excluded from clinical trials. The United States passed the Safety and Innovation Act (Food and Drug Administration Safety and Innovation Act [FDA-SIA]) in 2012 to increase study diversity and mandate reporting of certain demographics. The purpose of this study was to investigate demographic reporting and analysis among high-risk orthopaedic medical device trials and evaluate the effectiveness of the FDA-SIA in increasing diversity of study enrollment. Methods: The premarket approval database was queried for all original submissions approved by the Orthopedic Advisory Committee from January 1, 2003, to July 1, 2022. Study demographics were recorded. Weighted means of race, ethnicity, and sex were compared before and after FDA-SIA implementation with the US population. Results: We identified 51 orthopaedic trials with unique study data. Most Food and Drug Administration device trials reported age (98.0%) and sex (96.1%), but only 49.0% and 37.3% reported race and ethnicity, respectively. Only 23 studies analyzed sex, six analyzed race, and two analyzed ethnicity. Compared with the US population, participants were overwhelmingly White (91.36% vs. 61.63%, P , 0.001) with a significant underrepresentation of Black (3.65% vs. 12.41%, P = 0.008), Asian (0.86% vs. 4.8%, P = 0.030), and Hispanic participants (3.02% vs. 18.73%, P , 0.001) before 2013. The FDA-SIA increased female patient enrollment (58.99% vs. 47.96%, P = 0.021) but did not increase the enrollment of racial or ethnic minorities. Conclusion: Despite efforts to increase the generalizability of studies within the FDA-SIA, orthopaedic medical devices still fail to enroll

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Our Efforts Towards a Diversity Pledge

Mont¹,

Backstein²,

Browne³

et al. 2021

The Journal of Arthroplasty

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Reporting and Analyzing Demographics in the Journal of Arthroplasty: Are We Making Progress?

Cited by 11 publications

References 45 publications

Low Rates of Reporting and Analyzing Race and Ethnicity in Hand Surgery Randomized Controlled Trials: A Systematic Review

Low Rates of Reporting and Analyzing Race and Ethnicity in Hand Surgery Randomized Controlled Trials: A Systematic Review

Diversity in Orthopaedic Surgery Medical Device Clinical Trials: An Analysis of the Food and Drug Administration Safety and Innovation Act

Our Efforts Towards a Diversity Pledge

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