9. Demographic representation in the North American Spine Society Appropriate Use Criteria for Cervical Fusion and Degenerative Lumbar Spondylolisthesis

Abstract

BACKGROUND CONTEXT

In the United States (US), there have been increasing efforts for diverse clinical trial recruitment with hopes of addressing inequities in health care and providing representative data for clinical decision-making. There has been no published evidence to analyze the current state of spine literature and representation among its studies.

PURPOSE

The primary aim of this study was to investigate the racial and ethnic representation in studies referenced in the North American Spine Society (NASS) 2022 Appropriate Use Criteria (AUC) for Cervical Fusion (CF) and 2020 AUC Degenerative Lumbar Spondylolisthesis for (LS) were analyzed.

STUDY DESIGN/SETTING

Review.

PATIENT SAMPLE

Participants were pooled from studies included in the NASS CF and LS AUC.

OUTCOME MEASURES

The primary outcome measure of this study was participation-to-prevalence ratio (PPR). The numerator (participation) was defined as the representation of a demographic group pooled across included studies. The PPR denominator (prevalence) was defined as the representation of a demographic group in the US population.

METHODS

Articles included in the NASS 2022 CF and 2020 DLS AUC were analyzed. Main study details and the demographic characteristics they reported were collected. US census data from 2020 was used to calculate the representation of each demographic group relative to their proportion in the US population, demonstrated as participation-to-prevalence ratio (PPR). PPR<0.80 were classified as underrepresented and PPR>1.2 were classified as overrepresented.

RESULTS

A total of 84 studies published from 1998 to 2020 were included, 44 of which were CF AUC references and 40 of which were DLS AUC references. Race was reported in 8 (9.5%) of the studies, ethnicity in 4 (4.7%) and gender in 63 (75%). There were 43 US-based studies (24 CF AUC, 19 DLS AUC), 7 reported race and of those 5 were published after 2014. Of the US-based studies 57% (4/7) reported race and ethnicity separately, three reported Asian participants and 2 reported American Indian/Alaska Native participants. Representation of White participants was calculated using pooled data from all 7 studies and revealed an overrepresentation when compared to the US population (PPR=1.52). When the 2 studies that reported all demographic groups were analyzed, an overrepresentation of White participants was again demonstrated (PPR=1.45), in addition to an underrepresentation of Black, Hispanic, and Asian participants (PPR=0.82, 0.39, 0.67 respectively).

CONCLUSIONS

This study demonstrates a failure to consider race and ethnicity among the studies used to develop NASS AUCs for CF and DLS. Among the evidence base, the US studies that reported race and ethnicity revealed an underrepresentation of non-White demographics. The findings emphasize a need for intentional recruitment of more diverse and representative clinical research participants in the spine literature.

FDA Device/Drug Status

This abstract does not discuss or include any applicable devices or drugs.