One dose versus two doses of COVID-19 vaccine for the prevention of breakthrough infections among people previously infected with SARS-Cov-2.

Studies have suggested the effectiveness of COVID-19 vaccines in preventing SARS-CoV-2 reinfection among those previously infected. However, it is not yet clear if one dose of the vaccine is enough to prevent breakthrough infections compared to two doses. Using data from Optum deidentified COVID-19 Electronic Health Record (EHR) data set, we assessed breakthrough infection risks in individuals previously infected, comparing those with one vaccine dose to those with two doses. Propensity scores were applied to mitigate confounding factors. Follow-up spanned 6 months, beginning 2 weeks postvaccination. Among 213 845 individuals, those receiving one vaccine dose had a significantly higher breakthrough infection risk than the two-dose group (HR 1.69, 95% CI 1.54-1.85). This pattern was observed across genders, racial/ethnic groups, age categories, and vaccine types. This study reveals a substantial disparity in the risk of breakthrough infections between individuals receiving one versus two doses of the COVID-19 vaccine, suggesting that a single dose may not provide adequate protection against reinfection.

Signal detection of adverse events associated with gabapentinoid use for chronic pain.

INTRODUCTION: Gabapentinoids (GABA) prescribing as a potential and conceivably safer substitute for opioids has substantially increased. Understanding all potential adverse drug events (ADEs) associated with GABA will guide clinical decision-making for pain management. METHODS: A 20% sample of Medicare enrollees with new chronic pain diagnoses in 2017-2018 was selected. GABA users were those with >=30 consecutive days prescription in a year without opioid prescription. Opioid users were similarly defined. The control group used neither of these drugs. Propensity score match across three groups based on demographics and comorbidity was performed. We used proportional reporting ratio (PRR), Gamma Poisson Shrinker, and tree-based scan statistic (TBSS) to detect ADEs within 3, 6, and 12 months of follow-up. RESULTS: Immunity disorder was detected within 3 months of follow-up by PRR compared to opioid use (PRR:2.33), and by all three methods compared to controls. Complications of transplanted organs/tissues and schizophrenia spectrum/other psychotic disorders were consistently detected by PRR and TBSS within 3 months. Skin disorders were detected by TBSS; and stroke was detected by PRR within 3 months compared to opioid use (PRR:4.74). Some malignancies were detected by PRR within 12 months. Other signals detected in GABA users were neuropathy and nerve disorders. CONCLUSIONS: Our study identified expected and unexpected ADE signals in GABA users. Neurological signals likely related to indications for GABA use. Signals for immunity, mental/behavior, and skin disorders were found in the FDA adverse event reporting system database. Unexpected signals of stroke and cancer require further confirmatory analyses to verify.

Adjuvant chemotherapy in patients with invasive lobular carcinoma and use of the 21-gene recurrence score: A National Cancer Database analysis.

BACKGROUND: Invasive lobular carcinoma (ILC) is traditionally considered less responsive to chemotherapy. Although the Oncotype recurrence score (RS) has been validated to identify high-risk patients who benefit from chemotherapy, some studies have questioned its relevance in patients with ILC. The objective of this study was to better characterize potential use of the RS in these patients. METHODS: The National Cancer Database was used to identify women with stage I through III, T1 through T3, N0 or N1, hormone receptor-positive, HER2-negative ILC or invasive ductal carcinoma (IDC) who had an available RS between 2010 and 2016. Multivariable Cox regression was used to model the effect of variables on 5-year overall survival (OS). The Kaplan-Meier method was used to estimate OS according to the RS, nodal status, and chemotherapy. RESULTS: In total, 15,763 patients with ILC and 100,070 with IDC were identified. The mean age of patients with ILC and IDC was 59.2 ± 9.1 and 57.2 ± 9.8, respectively. A lower percentage of patients with ILC versus those with IDC had a high RS, defined as >25 (6.6% vs 16.0%; P < .0001). ILC patients with a high RS who had N0 or N1 disease received approximately 10% less chemotherapy compared with similar patients who had IDC. The results indicated that the RS had statistically significant prognostic value for patients with ILC. In addition, an absolute OS advantage was correlated with the receipt of chemotherapy by patients with ILC who had a high RS with N0 or N1 disease. CONCLUSIONS: Patients with ILC who have a high RS are treated less often with chemotherapy compared with similar patients who have IDC. Nevertheless, the RS has a prognostic as well as a predictive value in ILC, with an association between OS benefit and chemotherapy receipt in patients who have ILC with a high RS, especially if they have N1 disease. LAY SUMMARY: Invasive lobular carcinoma (ILC) is a subtype of breast cancer comprising about 15% of cases. The Oncotype recurrence score (RS) is a genetic test of breast tumors that helps predict which patients might benefit from chemotherapy. Some have doubted the relevance of the RS for patients with ILC. In this study, the authors show that the RS is relevant for patients who have ILC. The RS has the potential of predicting the risk of recurrence and identifying patients with ILC who might benefit from chemotherapy.

Signal Detection of Adverse Events Associated with Trastuzumab in a Cohort of Elderly Patients with Breast Cancer.

AIM: Utilization of signal detection methods in longitudinal claims data can improve post-marketing drug surveillance, but to date there has been limited application. The aim of this study is to use 3 approaches, the proportional reporting ratio, Gamma Poisson Shrinker, and tree-based scan statistic in detecting adverse drug events (ADEs) attributed to trastuzumab using an administrative claims dataset. METHODS: Using data from the Texas Cancer Registry and SEER linked to Medicare from 2010 to 2013, we conducted 1:2 propensity score matching. Breast cancer HER2+ patients treated with trastuzumab in addition to standard chemotherapy were matched to HER2- patients treated with standard chemotherapy. Inpatient and outpatient encounters up to 6 months from start of therapy were used to identify adverse events. RESULTS: A total of 4191 patients were included in the study. Across all methods, use of trastuzumab generated signals on 9 distinct body systems. Cardiomyopathy and heart valve disease were the most consistently detected signals. Clinical review determined that most signals represented known ADEs. CONCLUSIONS: We showed that claims data can be used to complement current ADE monitoring using common data mining methods with propensity score matching. Our analysis identified all expected ADEs associated with trastuzumab, and additional signals of valvular heart disorders.

Metformin and testosterone replacement therapy inversely associated with hormone-associated cancers (prostate, colorectal and male breast cancers) among older White and Black men.

BACKGROUND: The independent and joint association of metformin and testosterone replacement therapy (TTh) with the incidence of prostate, colorectal, and male breast cancers remain poorly understood, including the investigation of the risk of these cancers combined (HRCs, hormone-associated cancers) among men of different racial and ethnic background. METHODS: In 143,035 men (≥ 65 yrs old) of SEER-Medicare 2007-2015, we identified White (N = 110,430), Black (N = 13,520) and Other Race (N = 19,085) men diagnosed with incident HRC. Pre-diagnostic prescription of metformin and TTh was ascertained for this analysis. Weighted multivariable-adjusted conditional logistic and Cox proportional hazards models were conducted. RESULTS: We found independent and joint associations of metformin and TTh with incident prostate (odds ratio [OR]joint = 0.44, 95% confidence interval [CI]: 0.36-0.54) and colorectal cancers (ORjoint = 0.47, 95% CI: 0.34-0.64), but not with male breast cancer. There were also inversed joint associations of metformin and TTh with HRCs (ORjoint = 0.45, 95% CI: 0.38-0.54). Similar reduced associations with HRCs were identified among White, Black, and Other Race men. CONCLUSION: Pre-diagnostic use of metformin and TTh were, independently and jointly, inversely associated with incident prostate and colorectal cancers. The risk of HRCs was also reduced among White, Black and Other Race men. Greatest reduced associations of prostate and colorectal cancers and HRCs were mainly observed in combination of metformin and TTh. Larger studies are needed to confirm the independent and joint association of metformin plus TTh with these cancers in understudied and underserved populations.

De-escalation of Endocrine Therapy in Early Hormone Receptor-positive Breast Cancer: When Is Local Treatment Enough?

OBJECTIVE: To identify subgroups of hormone receptor-positive (HR+) breast cancer patients that might not benefit from adding endocrine therapy (ET) to their local treatment. BACKGROUND: De-escalation in breast cancer treatment has included surgery, radiation, and chemotherapy and has often focused on older patient populations. Systemic ET has yet to be de-escalated, though it carries serious side-effects, decreasing quality of life over 5 to 10 years. We hypothesize the 21-gene recurrence score (RS) could identify subgroups of younger patients whose long-term survival is unaffected by adjuvant ET. METHODS: The National Cancer Database was used to identify women aged ≥50, with HR+, HER2-negative tumors, ≤3 cm in size, N0 status, and a RS≤25, who underwent breast-conserving surgery in 2010 to 2016. Kaplan-Meier and Cox proportional hazards models were used to identify association between treatment and overall survival (OS). RESULTS: Of the 45,217 patients identified, 80.6% were 50 to 69 years old. 42,632 (94.3%) patients received ET and 2585 (5.7%) did not. The 5-year OS was 96.4% for patients receiving ET and 93.1% for those who did not (P < 0.001). After adjusting for all covariates, patients aged 50 to 69 with RS < 11 showed no statistically significant improvement in OS when adding ET to surgery, with or without radiation (P = 0.40). With RS 11 to 25, there was a significant improvement of OS with ET plus radiation (P < 0.001). CONCLUSIONS: Local treatment only, with de-escalation of long-term ET, for patients aged 50 to 69 with RS < 11, seems not to impact OS and should have an anticipated quality of life improvement. Prospective studies investigating this approach are warranted.

The 21-gene recurrence score in node-positive, hormone receptor-positive, HER2-negative breast cancer: a cautionary tale from an NCDB analysis.

PURPOSE: The 21-gene recurrence score assay (RS) has not been prospectively validated to predict adjuvant chemotherapy benefit in hormone receptor-positive (HR+), HER2-negative (HER2-), node-positive breast cancer patients. Nevertheless, de-escalation based on RS has been demonstrated and partially advocated by retrospective data. The purpose of this study was to identify subgroups of node-positive patients with low to intermediate RS who still benefit from adjuvant chemotherapy. METHODS: The National Cancer Database was used to identify 28,591 women with stage I-III, T1-T3, N1, HR+, HER2- breast cancer and a RS ≤ 25 between 2010 and 2016. Univariate and multivariate analyses were used to identify variables correlating with chemotherapy use and 5-year survival. Subgroup analysis was performed to discern patients in whom the use of adjuvant chemotherapy correlated with better survival. RESULTS: A 35% decline in chemotherapy use was observed from 2010 to 2016. Patients with younger age, higher RS, larger tumors and more positive lymph nodes, and those treated by mastectomy, axillary lymph node dissection and radiation, were more likely to receive chemotherapy. Chemotherapy use was associated with an improved 5-year survival (HR = 1.63, 95% CI 1.28-2.07). Upon subgroup analysis, this association was lost in patients > 70 years and those with a RS ≤ 11, while patients ≤ 70 with a RS of 12-25 treated with chemotherapy had an absolute 5-year survival advantage of 3.0% (HR = 1.91, 95% CI 1.42-2.57). CONCLUSION: Clinicians should be cautious when considering omission of adjuvant chemotherapy in patients ≤ 70 years, with HR+, HER2-, N1 tumors and a RS 12-25, at least until the results of the anticipated RxPONDER trial become available.

Prognosis and Chemotherapy Use in Breast Cancer Patients with Multiple Lymphatic Micrometastases: An NCDB Analysis.

BACKGROUND: The number of involved lymph nodes negatively affects prognosis in breast cancer patients. Nevertheless, current staging and treatment recommendations do not distinguish between patients with single versus multiple lymphatic micrometastases. In this study, we aim to better characterize these patients. METHODS: The National Cancer Database was retrospectively queried to identify 486,800 women with stage I-III, estrogen receptor-positive/progesterone receptor-positive/human epidermal growth factor receptor 2-negative (ER+/PR+/HER2-) breast cancer and nodal status of N0, N1mi with 1 (Nmic1) or more (Nmic > 1) involved nodes, and N1 with 1 involved node (N1.1), from 2010 to 2016. Patients with different nodal statuses were compared regarding treatment characteristics, survival, and benefit from chemotherapy by their 21-gene recurrence score (RS). RESULTS: Of the 23,072 N1mi patients, 88.3% were Nmic1 and 11.7% were Nmic > 1. Nmic > 1 patients were younger, had larger and higher-grade tumors, with more lymphovascular invasion, and were more commonly treated by axillary dissection, radiation, and chemotherapy than Nmic1 patients. In that, they were comparable with N1.1 patients. Five-year survival of Nmic > 1 patients (88.1%) was worse than Nmic1 patients (90.1%; p = 0.02), but similar to N1.1 patients (87.9%). Nmic1, Nmic > 1, and N1.1 patients with RS 11-25 exhibited a < 2% absolute survival benefit associated with chemotherapy. With RS > 25, Nmic > 1 patients showed a 3.5% benefit, similar to Nmic1 (4.8%) and lower than N1.1 (10.9%) patients. CONCLUSIONS: Nmic > 1 breast cancer patients have worse prognoses than Nmic1 patients, similar to N1.1 patients. Our data suggest those patients with RS 11-25 have minimal benefit from chemotherapy. These findings should be taken into account when discussing prognosis and considering chemotherapy in patients with lymphatic micrometastases.

Factors associated with endometrial cancer and hyperplasia among middle-aged and older Hispanics.

OBJECTIVE: While disparities in endometrial hyperplasia and endometrial cancer are well documented in Blacks and Whites, limited information exists for Hispanics. The objective is to describe the patient characteristics associated with endometrial hyperplasia symptoms, endometrial hyperplasia with atypia and endometrial cancer, and assess factors contributing to racial/ethnic differences in disease outcomes. METHODS: This single-center, retrospective study included women aged ≥50 years with ≥ two encounters for endometrial hyperplasia symptoms, endometrial hyperplasia with atypia and endometrial cancer between 2012 and 2016. Multivariate logistic regression models evaluated the predictors of endometrial cancer and hyperplasia. RESULTS: We included 19,865 women (4749 endometrial hyperplasia symptoms, 71 endometrial hyperplasias with atypia, 201 endometrial cancers) with mean age of 60.45 years (SD 9.94). The odds of endometrial hyperplasia symptoms were higher in non-Hispanic Blacks (Odds Ratio [OR] 1.56, 95% Confidence Interval [CI] 1.20-1.72), Hispanics (OR 1.35, 95% CI 1.22-1.49), family history of female cancer (OR 1.25, 95% CI 1.12-1.39), hypertension (OR 1.24, 95% CI 1.14-1.35), and birth control use (OR 1.29, 95% CI 1.15-1.43). Odds of endometrial cancer and atypical hyperplasia increased for ages 60-64 (OR 7.95, 95% CI 3.26-19.37; OR 3.66, 95% 1.01-13.22) and being obese (OR 1.61, 95% CI 1.08-2.41; OR: 6.60, 95% CI 2.32-18.83). Odds of endometrial cancer increased with diabetes (OR 1.68, 95% CI 1.22-2.32). CONCLUSION(S): Patients with obesity and diabetes had increased odds of endometrial cancer and hyperplasia with atypia. Further study is needed to understand the exogenous estrogen effect contributing to the increased incidence among Hispanics.

Healthcare utilization 9 months pre- and post- COVID-19 hospitalization among patients discharged alive.

BACKGROUND: Emerging evidence suggests that there is an increase in healthcare utilization (HCU) in patients due to Coronavirus Disease 2019 (COVID-19). We investigated the change in HCU pre and post hospitalization among patients discharged home from COVID-19 hospitalization for up to 9 months of follow up. STUDY DESIGN AND METHODS: This retrospective study from a United States cohort used Optum® de-identified Clinformatics Data Mart; it included adults discharged home post hospitalization with primary diagnosis of COVID-19 between April 2020 and March 2021. We evaluated HCU of patients 9 months pre and post -discharge from index hospitalization. We defined HCU as emergency department (ED), inpatient, outpatient (office), rehabilitation/skilled nursing facility (SNF), telemedicine visits, and length of stay, expressed as number of visits per 10,000 person-days. RESULTS: We identified 63,161 patients discharged home after COVID-19 hospitalization. The cohort of patients was mostly white (58.8%) and women (53.7%), with mean age 72.4 (SD± 12) years. These patients were significantly more likely to have increased HCU in the 9 months post hospitalization compared to the 9 months prior. Patients had a 47%, 67%, 65%, and 51% increased risk of ED (rate ratio 1.47; 95% CI 1.45-1.49; p < .0001), rehabilitation (rate ratio 1.67; 95% CI 1.61-1.73; p < .0001), office (rate ratio1.65; 95% CI 1.64-1.65; p < .0001), and telemedicine visits (rate ratio 1.5; 95% CI 1.48-1.54; p < .0001), respectively. We also found significantly different rates of HCU for women compared to men (women have higher risk of ED, rehabilitation, and telemedicine visits but a lower risk of inpatient visits, length of stay, and office visits than men) and for patients who received care in the intensive care unit (ICU) vs those who did not (ICU patients had increased risk of ED, inpatient, office, and telemedicine visits and longer length of stay but a lower risk of rehabilitation visits). Outpatient (office) visits were the highest healthcare service utilized post discharge (64.5% increase). Finally, the risk of having an outpatient visit to any of the specialties studied significantly increased post discharge. Interestingly, the risk of requiring a visit to pulmonary medicine was the highest amongst the specialties studied (rate ratio 3.35, 95% CI 3.26-3.45, p < .0001). CONCLUSION: HCU was higher after index hospitalization compared to 9 months prior among patients discharged home post-COVID-19 hospitalization. The increases in HCU may be driven by those patients who received care in the ICU.

Evaluating the impact of pre-diagnostic use of statins and testosterone replacement therapy on mortality outcomes in older men with hormone-related cancers: Surveillance, Epidemiology, and End Results-Medicare 2007-2015.

BACKGROUND: The link between the pre-diagnostic use of statins and testosterone replacement therapy and their impact on hormone-related cancers, prostate cancer, colorectal cancer, and male breast cancer survival remains a topic of controversy. Further, there is a knowledge gap concerning the joint effects of statins and testosterone replacement therapy on hormone-related cancer survival outcomes. OBJECTIVE: To examine the independent and joint effects of pre-diagnostic use of statins and testosterone replacement therapy on the risk of all-cause and cause-specific mortality among older men diagnosed with hormone-related cancers, including prostate cancer, colorectal cancer, and male breast cancer. METHODS: In 41,707 men (≥65 years) of Surveillance, Epidemiology, and End Results-Medicare 2007-2015, we identified 31,097 prostate cancer, 10,315 colorectal cancer, and 295 male breast cancer cases. Pre-diagnostic prescription of statins and testosterone replacement therapy was ascertained and categorized into four groups (Neither users, statins alone, testosterone replacement therapy alone, and Dual users). Multivariable-adjusted Cox proportional hazards and competing-risks (Fine-Gray subdistribution hazard) models were conducted. RESULTS: No significant associations were found in Cox-proportional hazard models for hormone-related cancers. However, in the Fine-Gray competing risk models among high-grade hormone-related cancers, statins alone had an 11% reduced risk of hormone-related cancer-specific death (hazard ratio: 0.89; 95% confidence interval: 0.81-0.99; p 0.0451). In the prostate cancer cohort with both statistical models, the use of testosterone replacement therapy alone had a 24% lower risk of all-cause death (hazard ratio: 0.76; 95% confidence interval: 0.59-0.97; p 0.0325) and a 57% lower risk of prostate cancer-specific death (hazard ratio: 0.43; 95% confidence interval: 0.24-0.75; p 0.0029). Similar inverse associations were found among aggressive prostate cancer cases with testosterone replacement therapy alone and statins alone. No significant associations were found in the colorectal cancer and male breast cancer sub-groups. CONCLUSION: Pre-diagnostic use of statins and testosterone replacement therapy showed a survival benefit with reduced mortality in high-grade hormone-related cancer patients (only statins) and aggressive prostate cancer patients in both statistical models. Findings of testosterone replacement therapy use in aggressive prostate cancer settings could facilitate clinical trials. Further studies with extended follow-up periods are needed to substantiate these findings.

Temporal Trends in Treatment and Outcomes of Endometrial Carcinoma in the United States, 2005-2020.

Endometrial cancer has continued to see a rising incidence in the US over the years. The main aim of this study was to assess current trends in patients' characteristics and outcomes of treatment for endometrial carcinoma over 16 years. A dataset from the National Cancer Database (NCDB) for patients diagnosed with endometrial carcinoma from 2005 to 2020 was used in this retrospective, case series study. The main outcomes and measures of interest included tumor characteristics, hospitalization, treatments, mortality, and overall survival. Then, 569,817 patients who were diagnosed with endometrial carcinoma were included in this study. The mean (SD) age at diagnosis was 62.7 (11.6) years, but 66,184 patients (11.6%) were younger than 50 years, indicating that more patients are getting diagnosed at younger ages. Of the patients studied, 37,079 (6.3%) were Hispanic, 52,801 (9.3%) were non-Hispanic Black, 432,058 (75.8%) were non-Hispanic White, and 48,879 (8.6%) were other non-Hispanic. Patients in the 4th period from 2017 to 2020 were diagnosed more with stage IV (7.1% vs. 5.2% vs. 5.4% vs. 5.9%; p < 0.001) disease compared with those in the other three periods. More patients with severe comorbidities (Charlson Comorbidity Index score of three) were seen in period 4 compared to the first three periods (3.9% vs. ≤1.9%). Systemic chemotherapy use (14.1% vs. 17.7% vs. 20.4% vs. 21.1%; p < 0.001) and immunotherapy (0.01% vs. 0.01% vs. 0.2% vs. 1.1%; p < 0.001) significantly increased from period 1 to 4. The use of laparotomy decreased significantly from 42.1% in period 2 to 16.7% in period 4, while robotic surgery usage significantly increased from 41.5% in period 2 to 64.3% in period 4. The 30-day and 90-day mortality decreased from 0.6% in period 1 to 0.2% in period 4 and 1.4% in period 1 to 0.6% in period 4, respectively. Over the period studied, we found increased use of immunotherapy, chemotherapy, and minimally invasive surgery for the management of endometrial cancer. Overall, the time interval from cancer diagnosis to final surgery increased by about 6 days. The improvements observed in the outcomes examined can probably be associated with the treatment trends observed.

Corticosteroids and Outcomes in Solid Organ Transplant Recipients Infected With Severe Acute Respiratory Syndrome Coronavirus 2.

Objective: To examine outcomes in organ transplant and nontransplant patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection during the initial 22 months of the pandemic. Patients and Methods: We used Optum electronic health records to compare outcomes between an adult transplant group and a propensity-matched nontransplant group that tested positive for SARS-CoV-2 from February 1, 2020, to December 15, 2021. Baseline characteristics, hospitalization, intensive care unit admission, mechanical ventilation, renal replacement therapy, inpatient, and 90-day mortality were compared between the transplant and nontransplant groups and among specific transplant recipients. Cox proportional analysis was used to examine hospitalization and mortality by organ transplant, medical therapy, sex, and the period of the pandemic. Results: We identified 876,959 patients with SARS-CoV-2 infection, of whom 3548 were organ transplant recipients. The transplant recipients had a higher risk of hospitalization (30.6% vs 25%, respectively; P<.001), greater use of mechanical ventilation (7.8% vs 5.6%, respectively; P<.001), and increased inpatient mortality (6.7% vs 4.7%, respectively; P<.001) compared with the nontransplant patients. The initiation of mechanical ventilation was significantly more frequent in the transplant group. After adjustment for baseline characteristics and comorbidities, the transplant group had a higher risk of hospitalization (odds ratio, 1.38; 95% confidence interval, 1.19-1.59), without a difference in mortality. In the transplant group, lung transplant recipients had the highest inpatient mortality (11.6%). Conclusion: Among patients with SARS-CoV-2 infection, the transplant recipients were at a higher risk of hospitalization and inpatient mortality; however, mortality was mainly driven by advanced age and comorbidities rather than by transplant status or immunosuppressive medications. Lung transplant recipients had the greatest inpatient and 90-day mortality.

Structured Evaluation and Management of Patients with COPD in an Accredited Program.

Background: Chronic obstructive pulmonary disease (COPD) is an ambulatory care-sensitive condition. Methods: We compared the impact of care received by patients with COPD at Joint Commission-accredited, disease-specific clinics and primary care clinics at an academic health care systemfrom April 2014 to March 2018. Patients with COPD ≥ 40 years old with ≥ 2 outpatient visits 30 days apart were identified. Baseline demographics, disease-specific performance measures, and health care utilization were compared between groups. Propensity matching was conducted and time to the first emergency department (ED) visit and hospitalization was performed using Cox regression analysis. Results: Of 4646 unique patients with COPD, 1114 were treated at disease-specific clinics and 3532 at primary care clinics. The entire group was predominantly female (58.8 %), non-Hispanic White (74.2 %) with a mean age of 65.4 ± 11.4 years consisting of current (47.6 %) or former smokers (38.4 %). In the disease-specific group, performance measures were performed more frequently, and lower rates of ED visits (hazard ratio [HR]=0.31, 95% confidence interval [CI] 0.18-0.54) and hospitalizations (HR 0.41, 95% CI 0.21-0.79) noted in comparison to the primary care group. Conclusions: In this observational study, the implementation of achronic disease management program through accredited disease-specific clinics for patients with COPD was associated with reduced all-cause ED visits and hospitalizations.

A Closer Look-Who Are We Screening for Lung Cancer?

Objective: To evaluate the characteristics of individuals receiving lung cancer screening (LCS) and identify those with potentially limited benefit owing to coexisting chronic illnesses and/or comorbidities. Patients and Methods: In this retrospective study in the United States, patients were selected from a large clinical database who received LCS from January 1, 2019, through December 31, 2019, with at least 1 year of continuous enrollment. We assessed for potentially limited benefit in LCS defined strictly as not meeting the traditional risk factor inclusion criteria (age <55 years or >80 years, previous computed tomography scan within 11 months before an LCS examination, or a history of nonskin cancer) or liberally as having the potential exclusion criteria related to comorbid life-limiting conditions, such as cardiac and/or respiratory disease. Results: A total of 51,551 patients were analyzed. Overall, 8391 (16.3%) individuals experienced a potentially limited benefit from LCS. Among those who did not meet the strict traditional inclusion criteria, 317 (3.8%) were because of age, 2350 (28%) reported a history of nonskin malignancy, and 2211 (26.3%) underwent a previous computed tomography thorax within 11 months before an LCS examination. Of those with potentially limited benefit owing to comorbidity, 3680 (43.9%) were because of severe respiratory comorbidity (937 [25.5%] with any hospitalization for coronary obstructive pulmonary disease, interstitial lung disease, or respiratory failure; 131 [3.6%] with hospitalization for respiratory failure requiring mechanical ventilation; or 3197 [86.9%] with chronic obstructive disease/interstitial lung disease requiring outpatient oxygen) and 721 (8.59%) with cardiac comorbidity. Conclusion: Up to 1 of 6 low-dose computed tomography examinations may have limited benefit from LCS.

Use of weight loss medications in relation with prostate, colorectal and male breast cancers among older men: SEER-Medicare 2007-2015.

BACKGROUND: The association of weight loss medications with prostate (PCa), colorectal (CRC) or male breast cancers, including assessment of these cancers combined (HRCs, hormone-associated cancers) remain poorly understood. Testosterone replacement therapy (TTh) is reported to be inversely associated with obesity, PCa and CRC, but it is unclear whether TTh modifies the association of weight loss medications with HRCs. METHODS: In 49,038 men (≥ 65 years) of SEER-Medicare, we identified 15,471 men diagnosed with PCa, 4836 with CRC, and 141 with male breast cancers. Pre-diagnostic prescription of weight loss medications and TTh was ascertained for this analysis. Weighted multivariable-adjusted conditional logistic and Cox proportional hazards (mortality) models were conducted. RESULTS: We found an inverse association between use of weight loss medications and incident PCa (OR 0.59, 95% CI 0.57-0.62), CRC (OR 0.86, 95% CI 0.80-0.92), and HRCs (OR 0.65, 95% CI 0.62-0.68). Similar associations were observed for advanced stage at diagnosis of PCa and CRC. Effects of weight loss medications on PCa and HRC remained significant irrespective of the use of TTh but were only suggestive with CRC with positive TTh use. No associations were observed with male breast cancer and HRCs mortality. CONCLUSION: Pre-diagnostic use of weight loss medications reduced the incidence of PCa, CRC, and HRCs. These associations persisted in the same direction irrespective of the history of TTh use. Future studies are needed to confirm these findings and to identify underlying biological mechanisms of weight loss medications and TTh on the risk of cancer.

Radiological-histopathological discordance in patients transplanted for HCC and its impact on post-transplant outcomes.

BACKGROUND AND AIMS: Contrast-enhanced cross-sectional imaging is the cornerstone in the diagnosis, staging, and management of HCC, including eligibility for liver transplantation (LT). Radiological-histopathological discordance may lead to improper staging and may impact patient outcomes. We aimed to assess the radiological-histopathological discordance at the time of LT in HCC patients and its impact on the post-LT outcomes. METHODS: We analyzed further the effect of 6-month waiting policy on the discordance. Using United Network for Organ Sharing-Organ Procurement and Transplantation Network (UNOS-OPTN) database, we examined the discordance between pre-LT imaging and explant histopathology for all adult HCC patients who received liver transplants from deceased donors between April 2012 and December 2017. Kaplan-Meier methods and Cox regression analyses were used to evaluate the impact of discordance on 3-year HCC recurrence and mortality. RESULTS: Of 6842 patients included in the study, 66.7% were within Milan criteria on both imaging and explant histopathology, and 33.3% were within the Milan based on imaging but extended beyond Milan on explant histopathology. Male gender, increasing numbers of tumors, bilobar distribution, larger tumor size, and increasing AFP are associated with increased discordance. Post-LT HCC recurrence and death were significantly higher in patients who were discordant, with histopathology beyond Milan (adj HR 1.86, 95% CI 1.32-2.63 for mortality and 1.32, 95% CI 1.03-1.70 for recurrence). Graft allocation policy with 6-month waiting time led to increased discordance (OR 1.19, CI 1.01-1.41), although it did not impact post-LT outcome. CONCLUSION: Current practice for staging of HCC based on radiological imaging features alone results in underestimation of HCC burden in one out of three patients with HCC. This discordance is associated with a higher risk of post-LT HCC recurrence and mortality. These patients will need enhanced surveillance to optimize patient selection and aggressive LRT to reduce post-LT recurrence and increase survival.

SARS-CoV-2 infection-induced immunity reduces rates of reinfection and hospitalization caused by the Delta or Omicron variants.

During a pandemic, effective vaccines are typically in short supply, particularly at onset intervals when the wave is accelerating. We conducted an observational, retrospective analysis of aggregated data from all patients who tested positive for SARS-CoV-2 during the waves caused by the Delta and Omicron variants, stratified based on their known previous infection and vaccination status, throughout the University of Texas Medical Branch (UTMB) network. Next, the immunity statuses within each medical parameter were compared to naïve individuals for the effective decrease of occurrence. Lastly, we conducted studies using mice and pre-pandemic human samples for IgG responses to viral nucleocapsid compared to spike protein toward showing a functional component supportive of the medical data results in relation to the immunity types. During the Delta and Omicron waves, both infection-induced and hybrid immunities were associated with a trend of equal or greater decrease of occurrence than vaccine-induced immunity in hospitalizations, intensive care unit admissions, and deaths in comparison to those without pre-existing immunity, with hybrid immunity often trending with the greatest decrease. Compared to individuals without pre-existing immunity, those vaccinated against SARS-CoV-2 had a significantly reduced incidence of COVID-19, as well as all subsequent medical parameters. Though vaccination best reduces health risks associated with initial infection toward acquiring immunity, our findings suggest infection-induced immunity is as or more effective than vaccination in reducing the severity of reinfection from the Delta or Omicron variants, which should inform public health response at pandemic onset, particularly when triaging towards the allotment of in-demand vaccinations.

Prescribing of Gabapentinoids with or without opioids after burn injury in the US, 2012-2018.

Burn injury pain manifests as a combination of inflammatory, nociceptive, and neuropathic features. While opioids are the mainstay of burn pain management, non-opioid medications, such as gabapentinoids, have also been considered as they target the central nervous system. Increased opioid adverse events and overdose deaths in the United States led to the 2014 and 2016 guidelines to reduce opioid prescribing and consider alternatives, such as gabapentinoids. In the context of burn, the rate of gabapentinoid prescribing at the national level is unknown and it is unclear whether any shift has occurred in prescribing practices over time. We conducted a population level cohort study of adult burn patients from 2012 to 2018 to evaluate the rates and determinants of gabapentinoid prescribing, with and without opioids. Of 98,001 patients with burn, 22,521 (22.98%) received opioids and/or gabapentinoids (GABA). GABA represented 2.4% of prescriptions in 2012, but increased to 7.2% by 2018, while GABA-opioid co-prescriptions increased from 2.3% to 5.1%. The rate of increase in GABA prescriptions was higher for those aged 50-65 years or residing in the South. After adjustment, GABA was 44% more likely to be prescribed in 2017 and 2018 compared to 2012 and 2013, opioids were 38% less likely, while co-prescribing did not show a statistically significant change. Our study showed a modest increase in gabapentinoids' outpatient prescribing for burn patients after the 2014 and 2016 guidelines, indicating more opportunities for prescribers to expand non-opioid pain management in this population.