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Background Pulse oximetry was widely used in hospitals and at home to monitor blood oxygen during the COVID-19 pandemic. There have been concerns regarding potential bias in pulse oximetry measurements for people with dark skin. We aimed to assess the effects of skin pigmentation on the accuracy of oxygen saturation measurement by pulse oximetry (SpO2) compared with the gold standard SaO2 measured by CO-oximetry. Methods We searched Ovid MEDLINE, Ovid Embase, and EBSCO CINAHL Plus (up to December 2021), as well as ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform (up to August 2021). We identified studies comparing SpO2 values in any population, in any care setting, using any type of pulse oximeter, with SaO2 by standard CO-oximetry; and measuring the impact of skin pigmentation or ethnicity on pulse oximetry accuracy. We performed meta-analyses for mean bias (the primary outcome in this review) and its standard deviations (SDs) across studies included for each subgroup of level of skin pigmentation and ethnicity. We calculated accuracy root-mean-square (Arms) and 95% limits of agreement based on pooled mean bias and pooled SDs for each subgroup. Results We included 32 studies (6505 participants); 27/32 (84.38%) in hospitals and none in people's homes. Findings of 14/32 studies (43.75%) were judged, via QUADAS-2, at high overall risk of bias. Fifteen studies measured skin pigmentation and 22 referred only to ethnicity. Compared with standard SaO2 measurement, pulse oximetry probably overestimates oxygen saturation in people with dark skin (pooled mean bias 1.11%; 95% confidence interval 0.29% to 1.93%) and people described as Black/African American (pooled mean bias 1.52%; 0.95% to 2.09%) (moderate- and low-certainty evidence). These results suggest that, for people with dark skin, pulse oximetry may overestimate blood oxygen saturation by around 1% on average compared with SaO2. The bias of pulse oximetry measurements for people with other levels of skin pigmentation, or those from the White/Caucasian group is more uncertain. The data do not suggest overestimation in people from other ethnic groups such as those described as Asian, Hispanic, or mixed ethnicity (pooled mean bias 0.31%, 0.09% to 0.54%), but this evidence is low certainty. Whilst the extent of mean bias is small or negligible for all the subgroups of population evaluated, the associated imprecision is unacceptably large (with the pooled SDs > 1%). Nevertheless, when the extents of measurement bias and precision are considered jointly in Arms, pulse oximetry measurements for all the subgroups appear acceptably accurate (with Arms < 4%). Conclusions Low-certainty evidence suggests that pulse oximetry may overestimate oxygen saturation in people with dark skin and people whose ethnicity is reported as Black/African American, compared with SaO2, although the overestimation may be quite small in hospital settings. The clinical importance of any overestimation will depend on the particular clinical circumstance. Pulse oximetry measurements appear accurate but imprecise for all levels of skin pigmentation. The evidence relates to clinician-measured oximetry in health care environments and may not be reflected in home pulse oximetry where other factors may also influence accuracy.
Background Pulse oximetry was widely used in hospitals and at home to monitor blood oxygen during the COVID-19 pandemic. There have been concerns regarding potential bias in pulse oximetry measurements for people with dark skin. We aimed to assess the effects of skin pigmentation on the accuracy of oxygen saturation measurement by pulse oximetry (SpO2) compared with the gold standard SaO2 measured by CO-oximetry. Methods We searched Ovid MEDLINE, Ovid Embase, and EBSCO CINAHL Plus (up to December 2021), as well as ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform (up to August 2021). We identified studies comparing SpO2 values in any population, in any care setting, using any type of pulse oximeter, with SaO2 by standard CO-oximetry; and measuring the impact of skin pigmentation or ethnicity on pulse oximetry accuracy. We performed meta-analyses for mean bias (the primary outcome in this review) and its standard deviations (SDs) across studies included for each subgroup of level of skin pigmentation and ethnicity. We calculated accuracy root-mean-square (Arms) and 95% limits of agreement based on pooled mean bias and pooled SDs for each subgroup. Results We included 32 studies (6505 participants); 27/32 (84.38%) in hospitals and none in people's homes. Findings of 14/32 studies (43.75%) were judged, via QUADAS-2, at high overall risk of bias. Fifteen studies measured skin pigmentation and 22 referred only to ethnicity. Compared with standard SaO2 measurement, pulse oximetry probably overestimates oxygen saturation in people with dark skin (pooled mean bias 1.11%; 95% confidence interval 0.29% to 1.93%) and people described as Black/African American (pooled mean bias 1.52%; 0.95% to 2.09%) (moderate- and low-certainty evidence). These results suggest that, for people with dark skin, pulse oximetry may overestimate blood oxygen saturation by around 1% on average compared with SaO2. The bias of pulse oximetry measurements for people with other levels of skin pigmentation, or those from the White/Caucasian group is more uncertain. The data do not suggest overestimation in people from other ethnic groups such as those described as Asian, Hispanic, or mixed ethnicity (pooled mean bias 0.31%, 0.09% to 0.54%), but this evidence is low certainty. Whilst the extent of mean bias is small or negligible for all the subgroups of population evaluated, the associated imprecision is unacceptably large (with the pooled SDs > 1%). Nevertheless, when the extents of measurement bias and precision are considered jointly in Arms, pulse oximetry measurements for all the subgroups appear acceptably accurate (with Arms < 4%). Conclusions Low-certainty evidence suggests that pulse oximetry may overestimate oxygen saturation in people with dark skin and people whose ethnicity is reported as Black/African American, compared with SaO2, although the overestimation may be quite small in hospital settings. The clinical importance of any overestimation will depend on the particular clinical circumstance. Pulse oximetry measurements appear accurate but imprecise for all levels of skin pigmentation. The evidence relates to clinician-measured oximetry in health care environments and may not be reflected in home pulse oximetry where other factors may also influence accuracy.
Assessment of blood oxygen saturation is an important measure of health on which many diagnostic and treatment decisions are based. Blood oxygen saturation is most commonly assessed via pulse oximetry, with increasing use across the home, clinic, and hospital settings during the COVID-19 pandemic. 1 However, inaccuracies in pulse oximetry measurement have come under scientific scrutiny over the past 2 years. [2][3][4][5][6] Professional organizations, lawmakers, and the public have actively engaged with the issue. 4 A known design flaw of the pulse oximeter is that patients with darker skin (compared with lighter skin) are more likely to experience occult hypoxemia-defined conceptually as substantial arterial hypoxemia (SaO 2 ) detected on blood gas but not noted on simultaneous pulse oximetry (SpO 2 ). 1 Less is known about whether underdiagnosis of hypoxemia for historically marginalized racial and ethnic groups has consequences.In their article "Racial and Ethnic Discrepancy in Pulse Oximetry and Delayed Identification of Treatment Eligibility Among Patients With COVID-19," Dr Fawzy and colleagues evaluate this measurement bias in pulse oximetry among a population of hospitalized patients diagnosed with COVID-19. 7 The authors show measurement bias was associated with differences in delay in recognizing patients' eligibility for COVID-19 treatment, with racial and ethnic minoritized groups being more affected. Although less visible, this is similar to the ways in which race-and ethnicity-based cutoffs in pulmonary function tests and estimated glomerular filtration fraction 8 lead to underestimation of disease severity among patients of racial and ethnic minoritized groups, which in turn delays treatment of severe lung disease and limits access to timely kidney replacement therapy, including transplantation.The study by Dr Fawzy and colleagues was a retrospective analysis using a large database from 5 well-resourced hospitals. 7 As in other investigations of pulse oximetry, the authors evaluated clinical SaO 2 and SpO 2 measurements within 10 minutes of each other, a design that allows for head-tohead comparison of pulse oximetry estimations of arterial oxygenation with the gold standard from blood gas analysis. Using race and ethnicity as a proxy for skin color, the authors chose to aggregate the data for Black−Hispanic patients and Black patients into a single study group.Dr Fawzy and colleagues reported higher rates of occult hypoxemia (SaO 2 <88% when SpO 2 was 92%-96%) for Asian, Black, and Hispanic patients compared with non-Hispanic White patients, as well as delayed or unrecognized eligibility for the US Centers for Disease Control and Prevention guidelineconcordant COVID-19 treatments (eg, steroids, remdesivir) for
guides triage and therapy decisions for COVID-19. Whether reported racial inaccuracies in oxygen saturation measured by pulse oximetry are present in patients with COVID-19 and associated with treatment decisions is unknown. OBJECTIVE To determine whether there is differential inaccuracy of pulse oximetry by race or ethnicity among patients with COVID-19 and estimate the association of such inaccuracies with time to recognition of eligibility for oxygen threshold-specific COVID-19 therapies. DESIGN, SETTING, AND PARTICIPANTSThis retrospective cohort study of clinical data from 5 referral centers and community hospitals in the Johns Hopkins Health System included patients with COVID-19 who self-identified as Asian, Black, Hispanic, or White.EXPOSURES Concurrent measurements (within 10 minutes) of oxygen saturation levels in arterial blood (SaO 2 ) and by pulse oximetry (SpO 2 ). MAIN OUTCOMES AND MEASURESFor patients with concurrent SpO 2 and SaO 2 measurements, the proportion with occult hypoxemia (SaO 2 <88% with concurrent SpO 2 of 92%-96%) was compared by race and ethnicity, and a covariate-adjusted linear mixed-effects model was produced to estimate the association of race and ethnicity with SpO 2 and SaO 2 difference. This model was applied to identify a separate sample of patients with predicted SaO 2 levels of 94% or less before an SpO 2 level of 94% or less or oxygen treatment initiation. Cox proportional hazards models were used to estimate differences by race and ethnicity in time to recognition of eligibility for guideline-recommended COVID-19 therapies, defined as an SpO 2 level of 94% or less or oxygen treatment initiation. The median delay among individuals who ultimately had recognition of eligibility was then compared. RESULTS Of 7126 patients with COVID-19, 1216 patients (63 Asian [5.2%], 478 Black [39.3%], 215 Hispanic [17.7%], and 460 White [37.8%] individuals; 507 women [41.7%]) had 32 282 concurrently measured SpO 2 and SaO 2 . Occult hypoxemia occurred in 19 Asian (30.2%), 136 Black (28.5%), and 64 non-Black Hispanic (29.8%) patients compared with 79 White patients (17.2%). Compared with White patients, SpO 2 overestimated SaO 2 by an average of 1.7% among Asian (95% CI, 0.5%-3.0%), 1.2% among Black (95% CI, 0.6%-1.9%), and 1.1% among non-Black Hispanic patients (95% CI, 0.3%-1.9%). Separately, among 1903 patients with predicted SaO 2 levels of 94% or less before an SpO 2 level of 94% or less or oxygen treatment initiation, compared with White patients, Black patients had a 29% lower hazard (hazard ratio, 0.71; 95% CI, 0.63-0.80), and non-Black Hispanic patients had a 23% lower hazard (hazard ratio, 0.77; 95% CI, 0.66-0.89) of treatment eligibility recognition. A total of 451 patients (23.7%) never had their treatment eligibility recognized, most of whom (247 [54.8%]) were Black. Among the remaining 1452 (76.3%) who had eventual recognition of treatment eligibility, Black patients had a median delay of 1.0 hour (95% CI, 0.23-1.9 hours; P = .01) longer than White patients. There was no signif...
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