Long-term economic outcomes of ureteral injury in the United States.

OBJECTIVES: Ureteral injuries (UIs) during surgical procedures can have serious consequences for patients. Although UIs can result in substantial clinical burden, few studies report the impact of these injuries on payer reimbursement and patient cost-sharing. This retrospective study evaluated 30-day, 90-day, and 1-year healthcare resource utilization for patients with UIs and estimated patient and payer costs. METHODS: Patients aged ≥ 12 years who underwent abdominopelvic surgery from January 2016 to December 2018 were identified in a United States claims database. Patients were followed for 1 year to estimate all-cause healthcare visits and costs for patients and payers. Surgeries resulting in UIs within 30 days from the surgery date were matched to surgeries without UIs to estimate UI-attributable visits and costs. RESULTS: Five hundred and twenty-two patients with UIs were included. Almost a third (29.9%) of patients with UIs had outpatient surgery. Patients with UIs had slightly more healthcare visits and a 15.3% higher 30-day hospital readmission rate than patients without UIs. Patient costs due to UIs were not statistically significant, but annual payer costs attributable to UIs were $38,859 (95% CI = 28,142-49,576), largely driven by inpatient costs. CONCLUSIONS: UIs add substantial cost for payers and result in more healthcare visits for patients. These findings highlight the importance of including inpatient and outpatient settings for UI prevention. Although UIs are rare, the associated patient and payer burdens are high; thus, protocols or techniques are needed to recognize and avert UIs as current guideline recommendations are lacking.

Though not common, injuries to the ureters, which carry urine from the kidneys to the bladder, can occur during surgeries on the abdomen. Ureter injuries can lead to discomfort, pain, infection, and death. Patients with ureter injuries can also require additional care from doctors, leading to increased costs for both patients and insurance companies. The researchers in this study calculated the costs of ureter injuries at 30-days, 90-days, and 1-year after surgery using anonymous information from insurance claims from patients who received abdominal surgery.Compared with patients who did not have a ureter injury from surgery, a higher percentage of those with ureter injuries had healthcare visits in the year following surgery and a greater chance of being readmitted to the hospital in the 30 days after surgery. Costs for both patients and insurance companies increased in the year after surgery. Insurance companies paid almost $39,000 more on average per patient with ureter injury in the year after surgery compared with costs for patients who did not have ureter injuries. Patients with ureter injuries paid approximately $1,000 more out-of-pocket in the year after surgery compared with patients without ureter injuries.This study showed that ureter injuries increased costs for both patients and insurance companies. Patients with ureter injuries needed more healthcare and the insurance companies for those patients had higher financial costs. Though ureter injuries are uncommon, this study supports efforts to minimize their occurrence to prevent these impacts on patients and the healthcare system.

Inventory of real-world data sources in Japan: Annual survey conducted by the Japanese Society for Pharmacoepidemiology Task Force.

PURPOSE: The Database Task Force of the Japan Society for Pharmacoepidemiology began its annual surveys of databases available for clinico and pharmacoepidemiological studies in 2010. In this report, we summarize the characteristics of the databases available in Japan based on the results of our 2021 survey to illustrate the recent developments in the infrastructure for database research in Japan. METHODS: We included 20 major databases from the academia, government, or industry that were accessible to third parties. We used a web-based questionnaire to ask the database providers about their characteristics, such as their organization, data source(s), numbers of individuals enrolled, age distribution, code(s) used, and average follow-up periods. RESULTS: We received responses from all 20 databases approached: eight hospital-based databases, six insurer-based databases, four pharmacy-based databases, and two in the "other" category. Among them, 17 contained information from medical claims, pharmacy claims, and/or Diagnosis Procedure Combination data. Most insurer databases contained health check-up data that could be attached to the claims component. Some hospital-based databases had data from electronic medical records. Most insurer-based databases collected data from the insurers of working-age employees and therefore had limited coverage of older people. Most databases coded their medication data using the Japanese reimbursement codes, and many provided Anatomical Therapeutic Chemical Classification codes. CONCLUSIONS: The number of databases available for clinico and pharmacoepidemiological research and the proportion of the population they cover are increasing in Japan. The differences in their characteristics mean that the appropriate database must be selected for a particular study purpose.

Effectiveness and Cost of Stenting in Ureteral Injury in Colorectal Surgeries in the US: 2015 - 2019.

Background: Intraoperative ureteral injury (IUI) during colorectal surgery can have devastating consequences. This study aimed to assess the clinical and economic impact of pre-operative ureteral stenting in colorectal surgeries. Methods: A retrospective cohort study was conducted using United States hospital data (October 2015 - December 2019). IUI incidence was examined across selected inpatient surgery types (elective colectomy, enterectomy, proctectomy, enterostomy, other colorectal procedures; emergency colectomy). Stenting effectiveness was evaluated as the difference in IUI and intraoperative detection rates between propensity score-matched groups. The additional hospital cost for stenting was also estimated considering the savings from IUIs that were potentially avoidable or detected by stenting. Results: In total, 283,549 colorectal surgeries were analyzed. Across surgery types, stent use and IUI incidence ranged from 1.47% - 8.86% and from 0.91% - 2.90%, respectively. Stents were used in 6.75% of elective colectomy cases, where they were associated with an absolute reduction of 1.14 percentage points (95% CI: -1.85 to -1.03) in IUI rate and a 21.6 percentage point reduction in the intraoperative detection rate. Additional hospital costs for stenting ranged from $1,464 - $4,436 across surgery types. Additional results varied by case but were consistent with the colectomy example. Conclusions: While effective in limited settings, the IUI reduction attributed to stenting and ability to shift IUI detection to the intraoperative setting could not offset the hospital cost of stent placement during colectomy (and colorectal surgery, in general). There thus remains an ongoing need in colorectal surgery for a universal, cost-effective solution to prevent IUI.

Abdominopelvic Surgery: Intraoperative Ureteral Injury and Prophylaxis in the United States, 2015-2019.

INTRODUCTION: Preoperative ureteral catheterization/stenting (stenting) and intraoperative diagnostic cystoscopy (cystoscopy) may help prevent or identify intraoperative ureteral injuries (IUIs) during abdominopelvic surgery. In order to provide a comprehensive, single source of data for health care decision makers, this study aimed to catalog the incidence of IUI and rates of stenting and cystoscopy across a wide spectrum of abdominopelvic surgeries. METHODS: We conducted a retrospective cohort analysis of United States (US) hospital data (October 2015-December 2019). IUI rates and stenting/cystoscopy use were investigated for gastrointestinal, gynecological, and other abdominopelvic surgeries. IUI risk factors were identified using multivariable logistic regression. RESULTS: Among approximately 2.5 million included surgeries, IUIs occurred in 0.88% of gastrointestinal, 0.29% of gynecological, and 1.17% of other abdominopelvic surgeries. Aggregate rates varied by setting and for some surgery types were higher than previously reported, especially in certain higher-risk colorectal procedures. Prophylactic measures were generally employed at a relatively low frequency, with cystoscopy used in 1.8% of gynecological procedures and stenting used in 5.3% of gastrointestinal and 2.3% of other abdominopelvic surgeries. In multivariate analyses, stenting and cystoscopy use, but not surgical approach, were associated with a higher risk of IUI. Risk factors associated with stenting or cystoscopy, as well as those for IUI, largely mirrored the variables reported in the literature, including patient demographics (older age, non-White race, male sex, higher comorbidity), practice settings, and established IUI risk factors (diverticulitis, endometriosis). CONCLUSION: Use of stenting and cystoscopy largely varied by surgery type, as did rates of IUI. The relatively low use of prophylactic measures suggests there may be an unmet need for a safe, convenient method of injury prophylaxis in abdominopelvic surgeries. Development of new tools, technology, and/or techniques is needed to help surgeons identify the ureter and avoid IUI and the resulting complications.

Clinical and economic outcomes of pharmacological stress tests in patients with a history of COVID-19.

BACKGROUND: Despite millions of COVID-19 cases in the United States, it remains unknown whether a history of COVID-19 infection impacts the safety of pharmacologic myocardial perfusion imaging stress testing (pharmacologic MPI). HYPOTHESIS: The aim of this study was to assess if a prior COVID-19 infection was associated with a higher risk of complications during and following pharmacologic MPI testing. METHODS: This retrospective cohort analysis included 179 803 adults (≥18 years) from the PharMetrics® Plus claims database who underwent pharmacologic MPI between March 1, 2020 and February 28, 2021. Patients with a history of COVID-19 infection (COVID-19 group) were compared with propensity-score matched no-COVID-19 history group for reversal agent use, 30-day resource use, and post-MPI cardiac events/procedures. RESULTS: The most commonly used stress agent was regadenoson (91.7%). The COVID-19 group (n = 6372; 3.5%) had slightly higher: reversal agent use (difference 1.13% [95% confidence interval [CI]: 0.33, 1.92]), all-cause costs (difference USD $128 [95% CI: $73-$181]), and office visits (81.5% vs. 77.0%) than the no-COVID-19 group. Prior COVID-19 infection did not appear to impact subsequent cardiac events/procedures. CONCLUSIONS: COVID-19 history was associated with slightly higher reversal agent use, all-cause costs, and office visits after pharmacologic MPI; however, the differences were not clinically meaningful. Concerns for use of stress agents in patients with prior COVID-19 do not appear to be warranted.

Secondary invasive fungal infection in hospitalised patients with COVID-19 in the United States.

BACKGROUND: Invasive fungal infections (IFIs) have been identified as a complication in patients with Coronavirus disease 2019 (COVID-19). To date, there are few US studies examining the excess humanistic and economic burden of IFIs on hospitalised COVID-19 patients. OBJECTIVES: This study investigated the incidence, risk factors, clinical and economic burden of IFIs in patients hospitalised with COVID-19 in the United States. PATIENTS/METHODS: Data from adult patients hospitalised with COVID-19 during 01 April 2020-31 March 2021 were extracted retrospectively from the Premier Healthcare Database. IFI was defined either by diagnosis or microbiology findings plus systemic antifungal use. Disease burden attributable to IFI was estimated using time-dependent propensity score matching. RESULTS: Overall, 515,391 COVID-19 patients were included (male 51.7%, median age: 66 years); IFI incidence was 0.35/1000 patient-days. Most patients did not have traditional host factors for IFI such as hematologic malignancies; COVID-19 treatments including mechanical ventilation and systemic corticosteroid use were identified as risk factors. Excess mortality attributable to IFI was estimated at 18.4%, and attributable excess hospital costs were $16,100. CONCLUSIONS: Invasive fungal infection incidence was lower than previously reported, possibly due to a conservative definition of IFI. Typical COVID-19 treatments were among the risk factors identified. Furthermore, diagnosis of IFIs in COVID-19 patients may be complicated because of the several non-specific shared symptoms, leading to underestimation of the true incidence rate. The healthcare burden of IFIs was significant among COVID-19 patients, including higher mortality and greater cost.

Comparative molecular profiling of antimicrobial resistance and phylogenetic characterization of multidrug-resistant Escherichia coli isolated from meat sources in 2009 and 2021 in Japan.

The global spread of antimicrobial resistance (AMR) is alarming. Escherichia coli is a Gram-negative bacterium that causes healthcare-associated infections and is a major threat to public health. Currently, no comprehensive antimicrobial surveillance of multidrug-resistant E. coli of diverse phylogroups along the meat value chain has been implemented in Higashihiroshima, Japan. Therefore, by employing the One Health approach, 1183 bacterial isolates, including 303 recovered from meat samples in 2009, were screened for the presence of antimicrobial resistance determinants using multiplex PCR and DNA sequencing techniques. Seventy-seven non-duplicate E. coli isolates that harbored AMR genes were subjected to antimicrobial susceptibility testing and the detection of integrons. Phylogenetic characterization, which has not been previously investigated, was used to assign E. coli to one of the eight phylogroups. Twenty-six out of 33 (78.8%) and 34 out of 44 (77.3%) E. coli isolates from 2009 and 2021 exhibited multidrug resistance (MDR) phenotypes, respectively. The most common clinical resistance was observed against ampicillin, tetracycline, kanamycin, sulfamethoxazole/trimethoprim, cefotaxime, and chloramphenicol. Overall, 22.1% (17/77) of the E. coli isolates carried extended-spectrum ß-lactamase (ESBL)-encoding genes and showed the ESBL-resistant phenotypes. For the two isolation years, AmpC/ESBL prevalence decreased from 42.4% in 2009 to 20.5% in 2021. The identified AMR genes included blaCTX-M-1, blaCTX-M-2, blaCTX-M-14, blaCTX-M-15, and blaSHV-12 (ESBL-types); blaSHV-1, blaTEM-1, blaTEM-135, and blaTEM-176 (narrow-spectrum types); blaCMY-4, blaADC-32, blaADC-216, blaACT-48, and blaACT-51 (AmpC types); and integrons. All E. coli isolates were negative for carbapenemase-encoding genes, whereas one isolate from 2009 carried mcr-5.1 allele. Approximately 52% of E. coli isolates identified in 2009 were assigned to phylogroup A compared to the 20.5% in 2021. Notably, the highest proportions of E. coli phylogroups exhibiting MDR were groups A, B1, and F, suggesting that members of these groups are mostly associated with drug resistance. This study highlights the role of meat as a significant reservoir of MDR E. coli and potential source for transmission of AMR genes. Our findings emphasize the importance of continuous monitoring to track the changes in the spread of antimicrobial resistance in the food chain.

Correcting for the effect of ambient pressure fluctuations on measured output from a linear accelerator with a sealed monitor chamber.

Objective.Ambient pressure fluctuations deform the walls of a sealed monitor chamber in a linear accelerator (LINAC) and affect the output. This study retrospectively quantified the output variations accompanying ambient pressure fluctuations in a LINAC equipped with a sealed monitor chamber and introduced a novel approach of calculating the adjusted output free from the effect of ambient pressure fluctuations.Approach.The output data for the 6 MV and 10 MV X-rays measured between March 2014 and September 2015 were analysed. This period was further divided into four sub-periods according to the output calibrations. Output behaviours were modelled using multiple regression analysis with ambient pressure and the time elapsed since the last calibration as explanatory variables. The output variations accompanying ambient pressure fluctuations were calculated using regression parameters and were subtracted from the measured outputs to obtain the adjusted outputs.Main results.The partial regression coefficients for ambient pressure varied from -2.3 × 10-4to -1.8 × 10-4cGy/MU/hPa for 6 MV and from -1.9 × 10-4to -1.2 × 10-4cGy/MU/hPa for 10 MV X-rays. These partial regression coefficient values were comparable among the four sub-periods and the two x-ray energies, respectively. These findings suggest that the degree of the output variations accompanying ambient pressure fluctuations is independent of x-ray energies and is determined by the internal structure of the chamber and the pressure differential between the inside and outside of the chamber. The adjusted outputs showed a better fit with the time trend line than the measured outputs.Significance.This study demonstrates a novel procedure for obtaining the adjusted outputs and allows precise observation of the output behaviours of a LINAC equipped with a sealed monitor chamber. Combined observation of the measured and adjusted output facilitates the detection of output anomalies, thus contributing to quality control (QC) of LINACs.

Physical oral care prevents ventilator-associated pneumonia in Vietnam: A prospective interventional study.

BACKGROUND: Ventilator-associated pneumonia (VAP) has emerged as a critical issue in the intensive care unit (ICU) because of its high burden on patients and medical staff. Here, we examined the potential for reducing VAP incidence through physical oral care interventions without any medication. METHODS: This prospective interventional study compared VAP incidence during an 8-month baseline period (usual oral care) and a 9-month intervention period (physical oral care with sponge brush) among patients who received mechanical ventilation for >48 h in a tertiary care hospital in Vietnam from 2017 to 2019. Physical oral care was provided by general ICU nurses who had been trained by dentists and infection control nurses. VAP was diagnosed using the Clinical Pulmonary Infection Score. RESULTS: In total, 423 patients were enrolled in the baseline group and 454 patients were enrolled in the intervention group; 303 and 300 patients, respectively, were included in the analysis. Two hundred thirty-eight VAP episodes were identified: 135 (44.6%) during the baseline period and 103 (34.3%) during the intervention period. Univariate analysis revealed significant reduction of VAP occurrence in the intervention period (odds ratio = 0.65; 95% confidence interval = 0.47-0.90; P = 0.010). The incidences of VAP per 1000 ventilator-days were 63.4 (135/2128) during the baseline period and 48.4 (103/2128) during the intervention period (P = 0.038). CONCLUSIONS: Physical oral care without any medication (e.g., chlorhexidine) reduced VAP incidence in the ICU. This method could be used to reduce VAP incidence, particularly in countries with limited medical resources.

Mirabegron and antimuscarinic use in frail overactive bladder patients in the United States Medicare population.

INTRODUCTION: Overactive bladder (OAB) and frailty are independently associated with patient burden. However, economic burden and treatment-taking behavior have not been well characterized among frail patients with OAB, which, given the varying safety and tolerability profiles of available treatments, is crucial. OBJECTIVES: To assess costs, health care resource utilization, treatment-taking behavior (persistence and adherence) to OAB medication in older, frail OAB patients. METHODS: This was a retrospective cohort study using international business machines MarketScan Medicare Supplemental claims data. Eligible frail patients (per Claims-based Frailty Index score) initiating mirabegron were 1:2 propensity score matched (based on age, sex, and other characteristics) with those initiating antimuscarinics and were followed up to 1 year. All-cause, per-person, per-month costs, health care encounters, persistence (median days to discontinuation assessed using Kaplan-Meier methods) and adherence (≥80% of proportion of days covered at Day 365) were compared. RESULTS: From 2527 patients with incident mirabegron (21%) or antimuscarinic (79%) dispensations, 516 incident mirabegron users (median age: 82 years, 64% female) were matched to 1032 incident antimuscarinic users (median age: 81 years, 62% female). Median cost was higher in mirabegron group ($1581 vs. $1197 per month); this was primarily driven by medication cost. There was no difference in medical encounters. Adherence (39.1% vs. 33.8%) and persistence (103 vs. 90 days) were higher in mirabegron users. CONCLUSIONS: Among frail older adults with OAB, mirabegron use was associated with higher costs and potential improvements in treatment-taking behaviors, particularly with respect to treatment adherence, versus those initiating antimuscarinics.

Effect of hyperhomocysteinemia on a murine model of smoke-induced pulmonary emphysema.

Hyperhomocysteinemia was reported to enhance endoplasmic reticulum (ER) stress and subsequent apoptosis in several cells. However, the precise mechanisms of smoking susceptibility associated with hyperhomocysteinemia has not been fully elucidated. This study included 7- to 9-week-old C57BL6 male mice induced with hyperhomocysteinemia and were exposed to cigarette smoke (CS). A549 cells (human alveolar epithelial cell line) were cultured with homocysteine and were exposed to cigarette smoke extract (CSE) to observe cell viability and expression of proteins related to the ER stress. After 6 months of CS exposure, pulmonary emphysema was more severely induced in the group under the condition of hyperhomocysteinemia compared to that in the control group. The apoptotic A549 cells increased as homocysteine concentration increased and that was enhanced by CSE. Protein expression levels of ER stress markers were significantly increased after simultaneous stimulation. Notably, vitamin B12 and folate supplementation improved ER stress after simultaneous stimulation of A549 cells. In this study, we showed that hyperhomocysteinemia exacerbates CS exposure-induced emphysema in mice, suggesting that hyperhomocysteinemia and CS stimulation enhance ER stress and subsequent induced apoptosis in alveolar epithelial cells. It was suggested that there is a synergistic effect between homocysteine and CS.

Combined role for YAP-TEAD and YAP-RUNX2 signalling in substrate-stiffness regulation of cardiac fibroblast proliferation.

Cardiac fibrosis is associated with increased stiffness of the myocardial extracellular matrix (ECM) in part mediated by increased cardiac fibroblast proliferation However, our understanding of the mechanisms regulating cardiac fibroblast proliferation are incomplete. Here we characterise a novel mechanism involving a combined activation of Yes-associated protein (YAP) targets RUNX Family Transcription Factor 2 (RUNX2) and TEA Domain Transcription Factor (TEAD). We demonstrate that cardiac fibroblast proliferation is enhanced by interaction with a stiff ECM compared to a soft ECM. This is associated with activation of the transcriptional co-factor, YAP. We demonstrate that this stiffness induced activation of YAP enhances the transcriptional activity of both TEAD and RUNX2 transcription factors. Inhibition of either TEAD or RUNX2, using gene silencing, expression of dominant-negative mutants or pharmacological inhibition, reduces cardiac fibroblast proliferation. Using mutants of YAP, defective in TEAD or RUNX2 activation ability, we demonstrate a dual role of YAP-mediated activation of TEAD and RUNX2 for substrate stiffness induced cardiac fibroblast proliferation. Our data highlights a previously unrecognised role of YAP mediated RUNX2 activation for cardiac fibroblast proliferation in response to increased ECM stiffness.

Compliance to Advisory Committee on Immunization Practices recommendations for pneumococcal vaccination.

We evaluated compliance to the ACIP pneumococcal vaccination recommendations issued in 2014 for adults aged ≥ 65 years and in 2012 for adults with high-risk (HR) conditions. The MarketScan® Commercial and Medicare Supplemental databases (January 2007-June 2019) were used to identify the cohorts of interest. Analyses for adults aged ≥ 65 years were adjusted to account for missing vaccination history. Two HR cohorts were identified. The HR1 cohort included patients with immunocompromising conditions, functional or anatomic asplenia, cerebrospinal fluid leak, or cochlear implant. The HR2 cohort included patients with chronic heart, lung, or liver disease; diabetes mellitus; alcoholism; cirrhosis; or cigarette smoking. Full compliance for those aged ≥ 65 years or in the HR1 cohort was defined as receipt of PCV13 and PPSV23, and partial compliance was defined as receipt of PCV13 or PPSV23. For those in the HR2 cohort, full compliance was defined as receipt of PPSV23. Annual compliance rates were estimated using the Kaplan-Meier method. Among those aged ≥ 65 years, partial compliance at 4 years post index was 53% and full compliance was 17% in adjusted analyses. In subjects ≥ 65 years receiving the first vaccination, 42% received the second vaccination by year 4. For the HR1 cohort, partial compliance was 19% and full compliance was 5% at 6 years post index date. For the HR2 cohort, full compliance was 20% at 6 years, with the highest rate in patients with diabetes (27%) and the lowest rate in patients with alcoholism (8%). Additional efforts are needed to maximize compliance to the ACIP pneumococcal vaccine recommendations among adults ≥ 65 years of age and adults with HR conditions including streamlined recommendations and single-dose vaccines. These efforts may subsequently reduce the incidence and burden of pneumococcal disease.

Estimating the causal effect of transient anemia status on renal and cardiovascular outcomes in community-dwelling patients in Japan at the beginning of impaired renal function using marginal structural modeling.

BACKGROUND: Anemia status may be transient. Causal associations between changes in anemia status over time and adverse outcome development are not well characterized in community-dwelling subjects at the beginning of impaired kidney function. METHODS: This retrospective cohort study used annual health checkup and medical and pharmacy claims data from the JMDC between January 2005 and June 2019. Community-dwelling subjects in Japan with a pre-index estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2 followed by a subsequent eGFR < 60 mL/min/1.73 m2 (index) were included. The composite renal outcome was ≥ 30% eGFR reduction over 3 years from baseline, serum creatinine doubling, progression to chronic dialysis, kidney transplantation, or eGFR < 15 mL/min/1.73 m2. The composite cardiovascular outcome was fatal and non-fatal unstable angina, myocardial infarction, heart failure, or cerebrovascular event. Time-dependent anemia risk was evaluated using Breslow's estimator and marginal structural Cox models (MSM). RESULTS: In 32,870 included subjects, 1,396 had anemia at baseline. Adverse outcome incidence was higher in the baseline anemic group, but absolute differences in renal and cardiovascular outcomes between groups were diminished after adjusting for baseline characteristics. In MSM, time-dependent anemia status was associated with higher risk of renal (hazard ratio [95% confidence interval]; 2.6 [1.7-3.8]) and cardiovascular (1.6 [1.2-2.2]) outcomes and mortality (2.8 [1.8-4.3]). Absolute differences in survival probabilities were retained over time but were clinically marginal (1.1-2.7% over 6 years). CONCLUSIONS: Even in subjects at the very early stage of impaired kidney function, early detection and treatment of anemia may help reduce the development of negative sequelae.

Vasomotor symptoms, sleep problems, and depressive symptoms in community-dwelling Japanese women.

AIM: To assess prevalence and characteristics of vasomotor symptoms in community-dwelling Japanese women. METHODS: These were cross-sectional analyses using data from the National Institute for Longevity Sciences-Longitudinal Study of Aging. The main outcome measures were prevalence and severity of hot flashes and sweating. Associations between hot flashes/sweating (slight, moderate, or severe vs none) and sleep problems were explored using logistic regression, with and without adjustment for age, daily physical activity, and number of urinations/night. Associations between hot flashes/sweating and sleep problems, depressive symptoms, and dietary variables were explored in logistic regression models or general linear models. RESULTS: A total of 1152 women between 40 and 91 years of age were enrolled. Hot flashes were reported by 24.5% of participants; with prevalence and severity highest in those 50-54 years or 2-5 years postmenopause. Sleep problems were reported 15 percentage points more frequently by women who reported hot flashes than by those without hot flashes. Adjusted odds ratios [95% CI] for difficulty in falling asleep and difficulty in sleeping through were 2.09 [1.565-2.796] and 2.07 [1.549-2.763]), respectively. Also, hot flashes were associated with higher risk of depressive symptoms (adjusted odds ratio [95% CI]: 2.99 [2.07-4.32]) and lower life satisfaction, self-esteem, and self-rated health status. A similar pattern was observed in women with and without sweating. No associations were found between hot flashes and dietary factors. CONCLUSIONS: Clear associations were found between hot flashes and sleeping problems, even after adjusting for potential confounding factors. Women who reported hot flashes also reported worse mental and physical health than those who did not report hot flashes.

The Costs and Healthcare Resource Utilization Associated with Anticholinergic Burden in Long-Stay Nursing Home Residents with Overactive Bladder in the US.

BACKGROUND: Overactive bladder (OAB) is a prevalent condition commonly treated with anticholinergic medications. The extent to which anticholinergic burden is associated with costs and healthcare resource use (HCRU) in the long-stay nursing home (LSNH) setting is currently unknown. OBJECTIVES: This research evaluated the impact of anticholinergic burden on HCRU and related costs among LSNH residents with OAB. METHODS: This was a cohort study based on 2013-2015 Minimum Data Set-linked Medicare claims data involving LSNH residents aged ≥ 65 years with OAB and having Parts A, B and D coverage 6 months pre- and ≥ 12 months post-nursing home admission date (index date). Cumulative anticholinergic burden was determined using the Anticholinergic Cognitive Burden scale and defined daily dose. Direct medical costs related to HCRU were examined. HCRU included inpatient, outpatient, emergency room (ER), and physician office visits. Costs and HCRU associated with levels of anticholinergic burden were evaluated using generalized linear models. RESULTS: A total of 123,308 LSNH residents with OAB were included in this study. Most residents (87.2%) had some level (12.8%, none; 18.0%, low; 41.9%, moderate; and 27.3%, high) of cumulative anticholinergic burden. Results indicate that all types of resource utilization were higher among those with any level of anticholinergic burden than those with no burden. The outpatient, ER, and physician costs tended to be higher with increasing anticholinergic burden. CONCLUSIONS: Costs and HCRU patterns reflected increasing trends with anticholinergic burden. Targeted efforts towards reducing anticholinergic burden among LSNH residents with OAB may result in decreases in costs and HCRU.

The Incidence and Risk Analysis of Lung Cancer Development in Patients with Chronic Obstructive Pulmonary Disease: Possible Effectiveness of Annual CT-Screening.

PURPOSE: Lung cancer is a serious complication in patients with chronic obstructive pulmonary disease (COPD) and accounts for approximately 15% of deaths in patients with COPD. However, with the exception of emphysema, few reports to date have been published on the factors that predict lung cancer development in COPD patients. It has been reported that patients with COPD develop lung cancer at a rate of 0.8% - 1.7%/year, but the incidence may be higher in the Japanese population. Therefore, we investigated the incidence of lung cancer and the lung cancer mortality rate in Japanese COPD patients, as well as factors that are associated with the development of lung cancer in COPD patients. PATIENTS AND METHODS: We followed up 224 patients with stable COPD and performed CT examinations at least once per year. The incidence of lung cancer was recorded and data at enrollment were compared with data of the group that did not develop lung cancer. RESULTS: Over a median follow-up period of 4.58 years, lung cancer was newly diagnosed in 19 patients; the incidence of lung cancer in this population was 1.85%/year. Patients who developed lung cancer had more severe emphysema assessed by CT and GOLD classification and were more likely to be current smokers than those who did not develop lung cancer. No other significant differences were observed between these two groups. Mortality was significantly increased in patients who developed lung cancer compared with those who did not. CONCLUSION: In COPD patients, the incidence of lung cancer is higher and the development of lung cancer worsens the prognosis; however, lung cancer development is unpredictable and attention should be paid to all patients. Annual CT screening is important for early detection of lung cancer.

Prevalence and Factors Associated with Cumulative Anticholinergic Burden Among Older Long-Stay Nursing Home Residents with Overactive Bladder.

BACKGROUND: Overactive bladder (OAB), the primary cause of urinary incontinence in nursing homes, is commonly treated with anticholinergic medications; however, the elderly population is vulnerable to the adverse effects associated with anticholinergic burden. Given the relatively high prevalence of OAB among nursing home residents, it is important to understand the magnitude of anticholinergic burden in this population. OBJECTIVES: The objectives of this study were to (1) examine the prevalence of cumulative anticholinergic burden among long-stay nursing home (LSNH) residents with OAB; and (2) identify the factors associated with varying levels of cumulative anticholinergic burden. METHODS: This was a retrospective, cohort study using Minimum Data Set-linked Medicare claims data. Anticholinergic burden was determined based on the Anticholinergic Cognitive Burden scale and patient-specific dosing using defined daily dose. The Andersen Behavioral Model framework was used to identify the predisposing, enabling, and need factors associated with levels of anticholinergic burden. Multivariable logistic regression models were developed to determine the factors associated with levels of anticholinergic burden. RESULTS: A total of 123,308 LSNH residents with OAB were identified; 87.2% had some degree of anticholinergic burden and 27.3% had high cumulative burden. Multiple factors were associated with higher levels of burden, including younger age, female sex, and non-Hispanic White ethnicity (predisposing factors); dual eligibility, Southern geographic region, and rural residence (enabling factors); and a number of comorbidities and concomitant medications (need factors). CONCLUSIONS: This study revealed a high level of anticholinergic burden among LSNH residents. Multiple factors were associated with a high level of burden. There is a need to optimize the use of anticholinergics due to their significant safety concerns in the LSNH setting.

Suitability of databases in the Asia-Pacific for collaborative monitoring of vaccine safety.

INTRODUCTION: Information regarding availability of electronic healthcare databases in the Asia-Pacific region is critical for planning vaccine safety assessments particularly, as COVID-19 vaccines are introduced. This study aimed to identify data sources in the region, potentially suitable for vaccine safety surveillance. This manuscript is endorsed by the International Society for Pharmacoepidemiology (ISPE). METHODS: Nineteen countries targeted for database reporting were identified using published country lists and review articles. Surveillance capacity was assessed using two surveys: a 9-item introductory survey and a 51-item full survey. Survey questions related to database characteristics, covariate and health outcome variables, vaccine exposure characteristics, access and governance, and dataset linkage capability. Other questions collated research/regulatory applications of the data and local publications detailing database use for research. RESULTS: Eleven databases containing vaccine-specific information were identified across 8 countries. Databases were largely national in coverage (8/11, 73%), encompassed all ages (9/11, 82%) with population size from 1.4 to 52 million persons. Vaccine exposure information varied particularly for standardized vaccine codes (5/11, 46%), brand (7/11, 64%) and manufacturer (5/11, 46%). Outcome data were integrated with vaccine data in 6 (55%) databases and available via linkage in 5 (46%) databases. Data approval processes varied, impacting on timeliness of data access. CONCLUSIONS: Variation in vaccine data availability, complexities in data access including, governance and data release approval procedures, together with requirement for data linkage for outcome information, all contribute to the challenges in building a distributed network for vaccine safety assessment in the Asia-Pacific and globally. Common data models (CDMs) may help expedite vaccine safety research across the region.