Laboratory Result Reference Ranges Stratified for Patient-Reported Sex and Ethnicity Are More Closely Associated With Postoperative Outcomes Than Currently Used Reference Ranges: A Retrospective Data Analysis

Background: A single laboratory range for all individuals may fail to take into account underlying physiologic differences based on sex and genetic factors. We hypothesized that laboratory distributions differ based on self-reported sex and ethnicity and that ranges stratified by these factors better correlate with postoperative mortality and acute kidney injury (AKI).

Methods: Results from metabolic panels, complete blood counts, and coagulation panels for patients in outpatient encounters were identified from our electronic health record. Patients were grouped based on self-reported sex (2 groups) and ethnicity (6 groups). Stratified ranges were set to be the 2.5th/97.5th percentile for each sex/ethnic group. For patients undergoing procedures, each patient/laboratory result was classified as normal/abnormal using the stratified and nonstratified (traditional) ranges; overlap in the definitions was assessed between the 2 classifications by looking for the percentage of agreement in result classifications of normal/abnormal using the 2 methods. To assess which definitions of normal are most associated with adverse postoperative outcomes, the odds ratio (OR) for each outcome/laboratory result pair was assessed, and the frequency that the confidence intervals of ORs for the stratified versus nonstratified range did not overlap was examined.

Results: Among the 300 unique combinations (race × sex × laboratory type), median proportion overlap (meaning patient was either "normal" or "abnormal" for both methodologies) was 0.86 [q1, 0.80; q3, 0.89]. All laboratory results except 6 overlapped at least 80% of the time. The frequency of overlap did not differ among the racial/ethnic groups. In cases where the ORs were different, the stratified range was better associated with both AKI and mortality (P < .001). There was no trend of bias toward any specific sex/ethnic group.

Conclusions: Baseline "normal" laboratory values differ across sex and ethnic groups, and ranges stratified by these groups are better associated with postoperative AKI and mortality as compared to the standard reference ranges.