Infusion Reactions With Alternative Therapies During the National Shortage of Iron Dextran.

Prior to the national shortage of iron dextran in early 2023, it was the most commonly administered intravenous iron infusion at our institution. After the shortage impacted the health system, alternatives such as iron sucrose and sodium ferric gluconate/sucrose were required that utilized lower doses given at more frequent patient visits. Coinciding with their more prevalent use, an increase in iron infusion reactions was observed. Our study analyzed 880 patients who received iron infusions in three Henry Ford Hospital clinics in metropolitan Detroit, Michigan, from July 2022-June 2023. The 74 reactions that occurred were most commonly associated with iron sucrose at the 500 mg dose (41/74, 55.41%, p < 0.0001). Most reactions observed across all iron formulations and doses were mild, with 83.7% being Grade 0 or 1 as defined by the United States Drug Allergy Registry (USDAR) grading scale for immediate reactions. Patients who experienced an infusion reaction were less likely to complete their infusion plans (OR 0.004 for iron dextran, OR 0.128 for iron sucrose, p < 0.0001), with infusions most commonly being completely discontinued thereafter, with a minority pursuing alternative options. More patients with lower number of doses scheduled for iron dextran completed their infusion schedules than those with more doses, but the opposite was seen for iron sucrose. We assessed the impact of the national shortage of iron dextran examining infusion reactions with various iron infusions and doses.

Differences in Patient-Reported Outcome Measures in Patients With Cancer Six Months Before Death.

PURPOSE: Patient-reported outcome measures (PROMs) provide a direct report of the patient's perspective, complementary to clinician assessment. Currently, understanding the real-time changes in PROM scores near the end of life remains limited. This study evaluated differences in mean PROM scores between patients with cancer within 6 months before death compared with surviving patients with cancer. METHODS: This retrospective case-control study uses the National Institutes of Health's Patient-Reported Outcomes Measurement Information System computer adaptive testing instruments to assess pain interference, physical function, fatigue, and depression. Patients dying within 6 months of PROM completion were selected as cases and matched to controls 1:3 by age at PROM completion, sex, cancer disease site, and cancer stage at diagnosis. Generalized estimating equation models assessed the difference in mean PROM score in cases compared with controls. RESULTS: A total of 461 cases and 1,270 controls from September 2020 to January 2023 were included. After adjustment for ethnicity, Charlson Comorbidity Index, and census tract median household income, significant differences in mean scores were demonstrated. Physical function domain showed the largest difference, with cases averaging 6.52 points lower than controls (95% CI, -8.25 to -4.80). Fatigue and pain interference domains showed a rise in PROMs scores by 4.83 points (95% CI, 2.94 to 6.72) and 4.33 points (95% CI, 2.53 to 6.12), respectively. CONCLUSION: Compared with controls, patients dying within 6 months of PROM completion demonstrated worse PROM scores in the four domains assessed. These findings suggest the utility of routinely collected PROMs as a real-time indicator of the terminal stage of life among patients with cancer to allow for earlier intervention with supportive oncology services.

Risk factors of emergency department visits following elective cervical and lumbar surgical procedures: a multi-institution analysis from the Michigan Spine Surgery Improvement Collaborative.

OBJECTIVE: Emergency department visits 90 days after elective spinal surgery are relatively common, with rates ranging from 9% to 29%. Emergency visits are very costly, so their reduction is of importance. This study's objective was to evaluate the reasons for emergency department visits and determine potentially modifiable risk factors. METHODS: This study retrospectively reviewed data queried from the Michigan Spine Surgery Improvement Collaborative (MSSIC) registry from July 2020 to November 2021. MSSIC is a multicenter (28-hospital) registry of patients undergoing cervical and lumbar degenerative spinal surgery. Adult patients treated for elective cervical and/or lumbar spine surgery for degenerative pathology (spondylosis, intervertebral disc disease, low-grade spondylolisthesis) were included. Emergency department visits within 90 days of surgery (outcome measure) were analyzed utilizing univariate and multivariate regression analyses. RESULTS: Of 16,224 patients, 2024 (12.5%) presented to the emergency department during the study period, most commonly for pain related to spinal surgery (31.5%), abdominal problems (15.8%), and pain unrelated to the spinal surgery (12.8%). On multivariate analysis, age (per 5-year increase) (relative risk [RR] 0.94, 95% CI 0.92-0.95), college education (RR 0.82, 95% CI 0.69-0.96), private insurance (RR 0.79, 95% CI 0.70-0.89), and preoperative ambulation status (RR 0.88, 95% CI 0.79-0.97) were associated with decreased emergency visits. Conversely, Black race (RR 1.30, 95% CI 1.13-1.51), current diabetes (RR 1.13, 95% CI 1.01-1.26), history of deep venous thromboembolism (RR 1.28, 95% CI 1.16-1.43), history of depression (RR 1.13, 95% CI 1.03-1.25), history of anxiety (RR 1.32, 95% CI 1.19-1.46), history of osteoporosis (RR 1.21, 95% CI 1.09-1.34), history of chronic obstructive pulmonary disease (RR 1.19, 95% CI 1.06-1.34), American Society of Anesthesiologists class > II (RR 1.18, 95% CI 1.08-1.29), and length of stay > 3 days (RR 1.29, 95% CI 1.16-1.44) were associated with increased emergency visits. CONCLUSIONS: The most common reasons for emergency department visits were surgical pain, abdominal dysfunction, and pain unrelated to index spinal surgery. Increased focus on postoperative pain management and bowel regimen can potentially reduce emergency visits. The risks of diabetes, history of osteoporosis, depression, and anxiety are areas for additional preoperative screening.

Risk factors for not reaching minimal clinically important difference at 90 days and 1 year after elective lumbar spine surgery: a cohort study.

OBJECTIVE: Patient-perceived functional improvement is a core metric in lumbar surgery for degenerative disease. It is important to identify both modifiable and nonmodifiable risk factors that can be evaluated and possibly optimized prior to elective surgery. This case-control study was designed to study risk factors for not achieving the minimal clinically important difference (MCID) in Patient-Reported Outcomes Measurement Information System Function 4-item Short Form (PROMIS PF) score. METHODS: The authors queried the Michigan Spine Surgery Improvement Collaborative database to identify patients who underwent elective lumbar surgical procedures with PROMIS PF scores. Cases were divided into two cohorts based on whether patients achieved MCID at 90 days and 1 year after surgery. Patient characteristics and operative details were analyzed as potential risk factors. RESULTS: The authors captured 10,922 patients for 90-day follow-up and 4453 patients (40.8%) did not reach MCID. At the 1-year follow-up period, 7780 patients were identified and 2941 patients (37.8%) did not achieve MCID. The significant demographic characteristic-adjusted relative risks (RRs) for both groups (RR 90 day, RR 1 year) included the following: symptom duration > 1 year (1.34, 1.41); previous spine surgery (1.25, 1.30); African American descent (1.25, 1.20); chronic opiate use (1.23, 1.25); and less than high school education (1.20, 1.34). Independent ambulatory status (0.83, 0.88) and private insurance (0.91, 0.85) were associated with higher likelihood of reaching MCID at 90 days and 1 year, respectively. CONCLUSIONS: Several key unique demographic risk factors were identified in this cohort study that precluded optimal postoperative functional outcomes after elective lumbar spine surgery. With this information, appropriate preoperative counseling can be administered to assist in shaping patient expectations.

Cervical disc arthroplasty versus anterior cervical discectomy and fusion: an analysis of the Michigan Spine Surgery Improvement Collaborative Database.

BACKGROUND CONTEXT: Anterior cervical discectomy and fusion (ACDF) and cervical disc arthroplasty (CDA) are established surgical options for the treatment of cervical radiculopathy, myelopathy, and cervical degenerative disc disease. However, current literature does not demonstrate a clear superiority between ACDF and CDA. PURPOSE: To investigate procedural and patient-reported outcomes of ACDF and CDA among patients included in the Michigan Spine Surgery Improvement Collaborative (MSSIC) database. DESIGN: Retrospective study of prospectively collected outcomes registry data. PATIENT SAMPLE: Individuals within the MSSIC database presenting with radiculopathy, myelopathy, or cervical spondylosis refractory to typical conservative care undergoing primary ACDF or CDA from January 4, 2016, to November 5, 2021. OUTCOME MEASURES: Perioperative measures (including surgery length, length of stay, return to OR, any complications), patient-reported functional outcomes at 2-year follow-up (including return to work, patient satisfaction, PROMIS, EQ-5D, mJOA). METHODS: Patients undergoing ACDF were matched 4:1 with those undergoing CDA; propensity analysis performed on operative levels (1- and 2- level procedures), presenting condition, demographics, and comorbidities. Initial comparisons performed with univariate testing and multivariate analysis performed with Poisson generalized estimating equation models clustering on hospital. RESULTS: A total of 2,208 patients with ACDF and 552 patients with CDA were included. Baseline demographics were similar, with younger patients undergoing CDA (45.6 vs 48.6 years; p<.001). Myelopathy was more frequent in ACDF patients (30% vs 25%; p=.015). CDA was more frequently planned as an outpatient procedure. Length of stay was increased in ACDF (1.3 vs 1.0 days; p<.001). Functional outcomes were similar, with comparable proportions of patients meeting minimal clinically important difference thresholds in neck pain, arm pain, PROMIS, EQ-5D, and mJOA score. After multivariate regression, no significant differences were seen in surgical or functional outcomes. CONCLUSIONS: This study demonstrates similar outcomes for those undergoing ACDF and CDA at 2 years. Previous meta-analyses of CDA clinical trial data adhere to strict inclusion and exclusion criteria required by clinical studies; this registry data provides "real world" clinical outcomes reflecting current practices for ACDF and CDA patient selection.

Association of prolonged symptom duration with poor outcomes in lumbar spine surgery: a Michigan Spine Surgery Improvement Collaborative study.

OBJECTIVE: There is a scarcity of large multicenter data on how preoperative lumbar symptom duration relates to postoperative patient-reported outcomes (PROs). The objective of this study was to determine the effect of preoperative and baseline symptom duration on PROs at 90 days, 1 year, and 2 years after lumbar spine surgery. METHODS: The Michigan Spine Surgery Improvement Collaborative registry was queried for all lumbar spine operations between January 1, 2017, to December 31, 2021, with a follow-up of 2 years. Patients were stratified into three subgroups based on symptom duration: < 3 months, 3 months to < 1 year, and ≥ 1 year. The primary outcomes were reaching the minimal clinically important difference (MCID) for the PROs (i.e., leg pain, Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS PF), EQ-5D, North American Spine Society satisfaction, and return to work). The EQ-5D score was also analyzed as a continuous variable to calculate quality-adjusted life years. Multivariable Poisson generalized estimating equation models were used to report adjusted risk ratios, with the < 3-month cohort used as the reference. RESULTS: There were 37,223 patients (4670 with < 3-month duration, 9356 with 3-month to < 1-year duration, and 23,197 with ≥ 1-year duration) available for analysis. Compared with patients with a symptom duration of < 1 year, patients with a symptom duration of ≥ 1 year were significantly less likely to achieve an MCID in PROMIS PF, EQ-5D, back pain relief, and leg pain relief at 90 days, 1 year, and 2 years postoperatively. Similar trends were observed for patient satisfaction and return to work. With the EQ-5D score as a continuous variable, a symptom duration of ≥ 1 year was associated with 0.04, 0.05, and 0.03 (p < 0.001) decreases in EQ-5D score at 90 days, 1 year, and 2 years after surgery, respectively. CONCLUSIONS: A symptom duration of ≥ 1 year was associated with poorer outcomes on several outcome metrics. This suggests that timely referral and surgery for degenerative lumbar pathology may optimize patient outcome.

Cognitive Function and Postoperative Outcomes in Patients with Head and Neck Cancer.

OBJECTIVE: Determine the relationship between cognitive function and postoperative outcomes. METHODS: This IRB-approved retrospective cohort study included all patients treated between August 2015 and March 2020 undergoing major surgery for aerodigestive cancer or cutaneous/thyroid cancer that required free-flap reconstruction at Henry Ford Hospital. Routine administration of the Montreal Cognitive Assessment (MoCA) was completed as part of preoperative psychosocial evaluation. Outcomes included postoperative diagnosis of delirium, discharge disposition, return to the emergency department within 30 days of surgery, and readmission within 30 days of surgery. Univariate and multivariate logistic regression were used to determine the associations between preoperative MoCA score and each outcome measure. RESULTS: One hundred thirty-five patients with HNC were included in the study (mean [SD] age, 60.7 [±10.8] years; 70.4% [n = 95] male; 83.0% [n = 112] White, 16.3% [n = 22] Black). The average preoperative MoCA score was 23.4 (SD ± 4.5). Based on the MoCA score, 35% (n = 47) scored ≥26 (i.e., normal cognitive status), 55.6% (n = 75) scored between 18 and 25 (i.e., mild impairment), 8.1% (n = 11) scored between 10 and 17 (i.e., moderate impairment), and 1.5% (n = 2) scored <10 (i.e., severe impairment). After adjusting for other variables, a lower MoCA score was associated with discharge disposition to a location other than home and prolonged length of hospital stay. CONCLUSIONS: Preoperative cognitive function in patients undergoing major head and neck surgery for head and neck cancer was associated with discharge destination and length of stay. LEVEL OF EVIDENCE: 3 Laryngoscope, 133:2999-3005, 2023.

Early breast cancer survival of black and white American women with equal diagnostic and therapeutic management.

PURPOSE: Breast cancer (BC) survival favors White versus Black Americans despite advances in screening and treatment. We hypothesized that these differences were dependent upon quality of care by analyzing long-term outcomes of 3139 early BC patients at our quaternary care center where uniform access and management of BC is provided to women irrespective of race. METHODS: Prospectively collected data for clinical stage I-II BC patients from our quaternary care cancer center were analyzed, focusing on disease-specific survival (DSS). Subgroup analyses included the overall cohort, triple-negative BC (TNBC), non-TNBC and HER2/neu positive patients. Multivariable analyses to evaluate associations of variables with DSS were performed for each subgroup. RESULTS: The overall cohort consisted of 3139 BC patients (1159 Black, 1980 White). Black and White patients did not differ by most baseline variables. Black patients had higher rates of TNBC (18% versus 10%, p < 0.0001). Kaplan-Meier analysis of all subgroups (overall, TNBC, non-TNBC, HER2/neu positive) did not reveal DSS differences between Black and White patients. Multivariable analysis of subgroups also did not find race to be associated with DSS. CONCLUSION: In this large, carefully controlled, long term, single-institution prospective cohort study DSS in Black and White early BC patients with equal access to high quality care, did not differ. While BC patients with adverse molecular markers did slightly worse than those with more favorable markers, there is no observable difference between Black and White women with the same markers. These observations support the conclusion that equal access to, and quality, of BC care abolishes racial disparities in DSS.

The Impact of Marital Status and Race in Obstructive Sleep Apnea.

OBJECTIVES: To examine the difference in survival of obstructive sleep apnea (OSA) based on marital status and race. METHODS: A single academic institution with data collection from 2005 to 2015. Patients with a diagnosis of OSA based on polysomnogram were abstracted from electronic medical records. Patients were classified as "married" or "unmarried." Race was self-reported as White, Black, Asian American, Hispanic/Latinx, Middle Eastern descent, or unrecorded and gathered from the electronic medical record. RESULTS: There were 6200 adults included. Of these, married patients composed 62.7% (n = 3890) of the patients. Patients were 51.3% White (n = 3182), 39.8% (n = 2467) were Black, and 8.9% (n = 551) were other/unrecorded. Married patients had better survival probabilities (p < .0001). Unmarried patients had 2.72 times the risk of death than those who were married (95% CI 1.78-4.20) when examining OSA survival. When examining survival of those on continuous positive airway pressure (CPAP) between married and unmarried patients, those who were unmarried had 2.00 (95% CI 1.58-2.54) times the risk of death than those who were married. Married Black patients demonstrated the best survival probabilities, followed by married White patients (p < .0001). Married patients had lower mean sleep efficiency than those that were unmarried (76.2% and 77.2%, respectively; p = .019). CONCLUSION: Married patients with OSA had increased survival compared to their single counterparts. Married Black patients had the highest survival.

The role of tocilizumab therapy in critically ill patients with severe acute respiratory syndrome coronavirus 2.

CONTEXT: Tocilizumab (TCZ), an interleukin-6 (IL-6) receptor antagonist, has been approved for use in rheumatoid arthritis and cytokine storm syndrome (CSS) associated with chimeric antigen receptor T cells treatment. Although TCZ is currently utilized in the treatment of critically ill coronavirus 2019 (COVID-19) patients, data on survival impact is minimal. OBJECTIVES: To assess the mortality rate of patients presenting with COVID-19 who received TCZ for suspected CSS. METHODS: This retrospective cohort study was conducted at Henry Ford Health System between March 10, 2020 and May 18, 2020. Data collection began in May 2020 and was completed in June 2020. Patients included in the study required hospital admission and had positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) polymerase chain reaction on nasopharyngeal swab. Eligibility criteria to receive TCZ, per hospital protocol, included any of the following: persistent fever, defined as 38.0 °C for at least 6 hours; a diagnosis of the acute respiratory distress syndrome (ARDS); serum ferritin ≥1,000 (ng/mL) or doubling within 24 hours; D-Dimer ≥ 5 (mg/L); serum lactate dehydrogenase ≥500 (IU/L); or interlukin-6 level ≥5 times the upper limit of normal. Dosing was initially determined by weight, then changed to a fixed 400 mg per hospital protocol. A comparator cohort was created from patients with COVID-19 and ARDS who did not receive TCZ. Patient survival was analyzed using the Kaplan-Meier method and compared by log rank test. A multivariable cox regression was applied to evaluate the association between TCZ and mortality. RESULTS: One hundred and thirty patients were evaluated in the study, 54 (41.5%) of whom received TCZ. Patients who received TCZ were younger (mean age, 63.8 vs. 69.4 years; p=0.0083) and had higher body mass indices (mean, 33.9 vs. 30.4; p=0.005). Of the comorbid conditions evaluated, heart disease was more common in the comparator group than the TCZ group (27 patients [35.5%] vs. 10 patients [18.5%]; p=0.034). A Kaplan-Meier survival curve demonstrated no difference in survival between TCZ and comparator patients (log rank p=0.495). In the multivariable Cox regression model for mortality at 30 days, treatment with TCZ was not associated with decreased mortality (hazard ratio, 1.1; 95% confidence interval, 0.53-2.3; p=0.77). Lower mean C-reactive protein (CRP) levels were demonstrated within 48 hours of disposition in the TCZ group (mean TCZ, 4.9 vs. mean comparator, 13.0; p=<0.0001). CONCLUSIONS: In this cohort study, no difference in survival was observed in critically ill patients treated with TCZ.

Effect of vitamin D nutrition on disease indices in patients with primary hyperparathyroidism.

In patients with primary hyperparathyroidism, the size of the adenoma is a major determinant of biochemical indices, disease severity, and manner of presentation. However, the large variation in adenoma weight, both within and between populations and a steady decline in parathyroid adenoma weights over time remain largely unexplained. Based on the results in a small number of patients almost two decades ago we proposed that vitamin D nutritional status of the patient explains both the disease manifestations and much of the variation in adenoma size. Accordingly, we examined the relationship between vitamin D nutrition, as assessed by serum levels of 25-hydroxyvitamin D, and parathyroid gland weight, the best available index of disease severity, in a large number of patients (n = 440) with primary hyperparathyroidism. A significant inverse relationship was found between serum 25-hydroxyvitamin D level and log adenoma weight (r = -0.361; p < 0.001). Also, the adenoma weight was significantly related directly to serum PTH, calcium, and alkaline phosphatase as dependent variables. In patients with vitamin D deficiency (defined as serum 25-hydroxyvitamin D levels 15 ng/mL or lower), gland weight, PTH, AP, and adjusted calcium were each significantly higher than in patients with 25-hydroxyvitamin D levels of 16 ng/mL or higher, but serum 1,25-dihydroxyvitamin D levels were similar in both groups. We interpret this to mean that suboptimal vitamin D nutrition stimulates parathyroid adenoma growth by a mechanism unrelated to 1,25-dihydroxyvitamin D deficiency. We conclude that variable vitamin D nutritional status in the population may partly explain the differences in disease presentation.