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This study investigated the incidence, rationales, and associated factors of inappropriate urinary catheter use among hospitalized older patients by gender. A longitudinal study of 321 patients with urinary catheter was conducted. Demographic factors, present health factors, urinary catheter factors, and indications of catheter use were collected. A total of 53.7% of urinary catheter-days were inappropriate. For both men and women, there was no significant difference in the incidence and common rationales of inappropriate use. Women, however, have another associated factor with inappropriate use. More tailored alternatives are needed for women to increase comfort to avoid inappropriate catheter use. [ABSTRACT FROM AUTHOR]

Sample size determination is essential during the planning phases of clinical trials. To calculate the required sample size for paired right-censored data, the structure of the within-paired correlations needs to be pre-specified. In this article, we consider using popular parametric copula models, including the Clayton, Gumbel, or Frank families, to model the distribution of joint survival times. Under each copula model, we derive a sample size formula based on the testing framework for rank-based tests and non-rank-based tests (i.e., logrank test and Kaplan- Meier statistic, respectively). We also investigate how the power or the sample size was affected by the choice of testing methods and copula model under different alternative hypotheses. In addition to this, we examine the impacts of paired-correlations, accrual times, follow-up times, and the loss to follow-up rates on sample size estimation. Finally, two real-world studies are used to illustrate our method and R code is available to the user. [ABSTRACT FROM AUTHOR]

Sample size determination is essential during the planning phases of a study. When the study endpoint is the time to an event, Cox proportional hazard model is the traditional technique to analyze the effects of covariates on survival time. In contrast to the proportional hazard model, the additive hazard (AH) model specifies that the effect of covariates additively increases or decreases the hazard function. The popularity of this model is that it gives a more intuitive interpretation without the proportional hazard assumption. Because there is no literature estimating the required sample size based on the AH model, we provide a flexible formula for calculating the required sample size. The proposed formula incorporates time-independent and time-dependent effects of covariates without complicated mathematical calculations. The performance of the method was evaluated by extensive simulations. Finally, some pilot studies are shown to illustrate the applications. [ABSTRACT FROM PUBLISHER]

Aim The present study aimed to identify the health profiles of older adults by using latent class analysis to investigate health heterogeneity and to determine what factors predicted healthy aging among an oldest-old sample cohort that was followed up for 14 years in Taiwan. Methods Data were drawn from five waves (carried out in 1993, 1996, 1999, 2003 and 2007) of the Taiwan Longitudinal Study on Aging to examine the changes in health heterogeneity in a nationally representative oldest-old cohort of Taiwanese. Overall, data from a total of 11 145 observations of 3155 older adults were considered. The influential factors predicting health changes were analyzed by using a generalized estimating equation. Results The results showed that four health profiles were identified among the aging population observed in the Taiwan Longitudinal Study on Aging. With increasing age, the combined effects of the physical functioning, cognitive and emotional health, and comorbidities of older adults significantly impact their health changes. Apart from health deteriorating with age and sex disparities, educational and economic status, health behaviors, and social participation at the individual level were found to be the robust factors in predicting healthy aging. Conclusions In considering what factors impact healthy aging, we suggest that a person-centered approach would be useful and critical for policy makers to understand the compositions of health profiles and the influencing factors in view of a life-course perspective. Based on the factors identified as influencing healthy aging at the individual level, it is imperative from a policy-making perspective to maximize opportunities for healthy aging. Geriatr Gerontol Int 2017; 17: 697-707. [ABSTRACT FROM AUTHOR]

Determination of an adequate sample size is critical to the design of research ventures. For clustered right-censored data, Manatunga and Chen [Sample size estimation for survival outcomes in cluster-randomized studies with small cluster sizes. Biometrics. 2000;56(2):616–621] proposed a sample size calculation based on considering the bivariate marginal distribution as Clayton copula model. In addition to the Clayton copula, other important family of copulas, such as Gumbel and Frank copulas are also well established in multivariate survival analysis. However, sample size calculation based on these assumptions has not been fully investigated yet. To broaden the scope of Manatunga and Chen [Sample size estimation for survival outcomes in cluster-randomized studies with small cluster sizes. Biometrics. 2000;56(2):616–621]'s research and achieve a more flexible sample size calculation for clustered right-censored data, we extended the work by assuming the marginal distribution as bivariate Gumbel and Frank copulas. We evaluate the performance of the proposed method and investigate the impacts of the accrual times, follow-up times and the within-clustered correlation effect of the study. The proposed method is applied to two real-world studies, and the R code is made available to users. [ABSTRACT FROM PUBLISHER]

The Shewhart-type control chart is traditionally developed under the normality assumption. In practice, however, this assumption may not hold. Because the skew normal distribution represents a broad distribution class and is more flexible than is the normal distribution, we propose two new control charts to monitor process mean and spread for skew normal distributed data. Moreover, to facilitate practical implementation, tables of charting constants are provided. We conducted simulation studies to compare the false alarm rates, and the results show that new proposed charts perform better than others as skewness increases. Finally, an illustrative example is provided. [ABSTRACT FROM PUBLISHER]

Current status data arise naturally from tumorigenicity experiments, epidemiology studies, biomedicine, econometrics and demographic and sociology studies. Moreover, clustered current status data may occur with animals from the same litter in tumorigenicity experiments or with subjects from the same family in epidemiology studies. Because the only information extracted from current status data is whether the survival times are before or after the monitoring or censoring times, the nonparametric maximum likelihood estimator of survival function converges at a rate of n 1∕3 to a complicated limiting distribution. Hence, semiparametric regression models such as the additive hazards model have been extended for independent current status data to derive the test statistics, whose distributions converge at a rate of n 1∕2, for testing the regression parameters. However, a straightforward application of these statistical methods to clustered current status data is not appropriate because intracluster correlation needs to be taken into account. Therefore, this paper proposes two estimating functions for estimating the parameters in the additive hazards model for clustered current status data. The comparative results from simulation studies are presented, and the application of the proposed estimating functions to one real data set is illustrated. Copyright © 2013 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Background: Limited efficacy has been observed when using opioids to treat neuropathic pain. Lidocaine patches reduce neuropathic pain in postherpetic neuralgia, but their benefits for cancer-related neuropathic pain remain unclear. This study aimed to investigate a treatment for cancer-related neuropathic pain. Methods: We conducted a prospective, open-label, single-arm study to assess the efficacy and safety of lidocaine transdermal patches in patients experiencing localized, superficial, neuropathic cancer pain. Terminal cancer patients already receiving opioid treatment participated in the 3-day study. The primary endpoint was pain intensity evaluated by the numerical rating scale (NRS). The secondary endpoints were the pain relief score and the quality of analgesic treatment. Results: The results showed a significant difference in the median NRS over 3 days (Kruskal–Wallis test, p < 0.0001). The median NRS pain intensity from Day 1 to Day 3 was 4.0 with 95% C.I. (3.3, 5.0), 3.0 (2.5, 3.5), and 2.6 (2.0, 3.0), respectively. The difference between the median NRS pain intensities of any 2 days was significant (Wilcoxon signed-rank test, p < 0.0001). The generalized estimating equation (GEE) estimation model showed significant differences between the NRS pain intensities on any 2 days. There was no significant difference in the pain relief score or the quality of analgesic treatment. Conclusions: In this study, the 5% lidocaine transdermal patch reduced the NRS pain intensity in neuropathic cancer patients already receiving opioid treatment. Treatment of localized and superficial neuropathic pain caused by cancer was well tolerated and effective. [ABSTRACT FROM AUTHOR]

Clustered right-censored data often arise from tumorigenicity experiments and clinical trials. For testing the equality of two survival functions, Jung and Jeong extended weighted logrank (WLR) tests to two independent samples of clustered right-censored data, while the weighted Kaplan-Meier (WKM) test can be derived from the work of O'Gorman and Akritas. The weight functions in both classes of tests (WLR and WKM) can be selected to be more sensitive to detect a certain alternative; however, since the exact alternative is unknown, it is difficult to specify the selected weights in advance. Since WLR is rank-based, it is not sensitive to the magnitude of the difference in survival times. Although WKM is constructed to be more sensitive to the magnitude of the difference in survival times, it is not sensitive to late hazard differences. Therefore, in order to combine the advantages of these two classes of tests, this paper developed a class of versatile tests based on simultaneously using WLR and WKM for two independent samples of clustered right-censored data. The comparative results from a simulation study are presented and the implementation of the versatile tests to two real data sets is illustrated. Copyright © 2009 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Background: Evidence is limited on excess risks of cardiovascular diseases (CVDs) associated with ambient air pollution in diabetic populations. Survival analyses without considering the spatial structure and possible spatial correlations in health and environmental data may affect the precision of estimation of adverse environmental pollution effects. We assessed the association between air pollution and CVDs in type 2 diabetes through a Bayesian spatial survival approach.Methods: Taiwan's national-level health claims and air pollution databases were utilized. Fine individual-level latitude and longitude were used to determine pollution exposure. The exponential spatial correlation between air pollution and CVDs was analyzed in our Bayesian model compared to traditional Weibull and Cox models.Results: There were 2072 diabetic patients included in analyses. PM2.5 and SO2 were significant CVD risk factors in our Bayesian model, but such associations were attenuated or underestimated in traditional models; adjusted hazard ratio (HR) and 95% credible interval (CrI) or confidence interval (CI) of CVDs for a 1 μg/m3 increase in the monthly PM2.5 concentration for our model, the Weibull and Cox models was 1.040 (1.004-1.073), 0.994 (0.984-1.004), and 0.994 (0.984-1.004), respectively. With a 1 ppb increase in the monthly SO2 concentration, adjusted HR (95% CrI or CI) was 1.886 (1.642-2.113), 1.092 (1.022-1.168), and 1.091 (1.021-1.166) for these models, respectively.Conclusions: Against traditional non-spatial analyses, our Bayesian spatial survival model enhances the assessment precision for environmental research with spatial survival data to reveal significant adverse cardiovascular effects of air pollution among vulnerable diabetic patients. [ABSTRACT FROM AUTHOR]

We assessed the effect of atosiban on pregnancy outcomes following in vitro fertilization (IVF) treatment among infertile women requiring different numbers of embryo transfer (ET) cycles (i.e., one, two, and more than two ET cycles). A longitudinal cohort study was conducted by utilizing the data from the Assisted Reproductive Technology Center in a university tertiary hospital during 2007–2017. Patients receiving IVF treatment with at least one ET cycle were included. Pregnancy outcomes following IVF treatment, including biochemical, clinical, and ongoing pregnancies, were investigated. The association between atosiban and IVF pregnancy was assessed using logistic generalized estimating equation models, with adjustment for time-varying clinical characteristics (e.g., maternal age) across multiple ET cycles for an individual. 403 women with 838 ET cycles were included, where 165 patients required one ET cycle, 133 patients required two ET cycles (a total of 266 ET cycles), and 105 patients required more than two ET cycles (a total of 407 ET cycles). Atosiban use was not significantly associated with pregnancy outcomes among all study infertile women undergoing IVF treatment. However, the results for women requiring more than two ET cycles showed significantly increased pregnancy rates associated with atosiban use (i.e., odds ratios [95% confidence interval] of 4.40 [1.52, 12.73] and 2.85 [1.45, 5.60] for clinical and ongoing pregnancies, respectively). This association was not observed for the women requiring only one or two ET cycles. Atosiban is a potential treatment for enhancing IVF pregnancy, especially among infertile women requiring more than two ET cycles. [ABSTRACT FROM AUTHOR]

Laparoscopic (LPD) and robotic pancreaticoduodenectomy (RPD) are both challenging procedures. The feasibility and safety of simultaneously developing LPD and RPD remain unreported. We retrospectively reviewed the data of patients undergoing LPD or RPD between 2014 and 2021. A total of 114 patients underwent minimally invasive pancreaticoduodenectomy (MIPD): 39 LPDs and 75 RPDs. The learning process of LPD and RPD were similar. The cutoff points of the learning curve were LPD, 13th patient (the 27th patient of MIPD), and RPD, 18th patient (the 31st patient of MIPD) according the cumulative sum analysis of operative time. A decrease in the operative time was associated with the case sequence (p < 0.001) but not with the surgical approach (p = 0.36). The overall surgical outcomes were comparable between both the LPD and RPD groups. When evaluating the learning curve impact on MIPD, LPD had higher major complication (≧ Clavien–Dindo grade III), bile leak and wound infection rates in the pre-learning curve phase than those in the after-learning curve phase, while RPD had similar surgical outcomes between two phases. Simultaneous development of LPD and RPD is feasible and safe for experienced surgeons, with similar learning process and comparable surgical outcomes. [ABSTRACT FROM AUTHOR]

Background: Obesity increases surgical risks in various abdominal surgeries and its impact on open pancreaticoduodenectomy (OPD) and minimally invasive pancreaticoduodenectomy (MIPD) remains unknown. This study aimed to compare the surgical outcomes of OPD and MIPD in obese and non-obese patients by propensity score matching (PSM) analysis during the implementation of MIPD. Methods: We retrospectively reviewed all pancreaticoduodenectomies from December 2014 to May 2021. Obesity was defined as body mass index > 25 kg/m2 according to World Health Organization International Obesity Task Force. PSM was used to minimize the selection bias of MIPD. Results: Among 462 pancreaticoduodenectomies (339 OPDs, 123 MIPDs), there were 313 patients in the non-obese group (MIPD: 78, OPD: 235) and 149 patients in the obese group (MIPD: 45, OPD: 104). After PSM, there were 70 MIPD/106 OPD patients in the non-obese group and 38 MIPD/54 OPD patients in the obese group. The obese MIPD patients had more fluid collection (36.8% vs 9.8%, p = 0.002), a higher Clavien–Dindo (CD) grade (p = 0.007), more major complications (42.1% vs 14.8%, p = 0.004), and longer operative times (306 min vs 264 min, p < 0.001) than the obese OPD patients. The non-obese MIPD patients had lower CD grades (p = 0.02), longer operative times (294 vs 264 min, p < 0.001), and less blood loss (100 mL vs 200 mL) than the non-obese OPD patients. MIPD was a strong predictor of major complication (CD ≥ 3) in obese patients (odds ratio 3.11, 95% CI: 1.40–6.95, p = 0.005). Conclusions: Minimally invasive approaches deteriorate the CD grade, fluid collection, and major complications in obese patients undergoing pancreaticoduodenectomy during the initial development period. Non-obese patients may benefit from MIPD over OPD in terms of less blood loss and lower CD grades. The impact of BMI on MIPD should be considered when assessing the surgical risks. [ABSTRACT FROM AUTHOR]

The association between human epidermal growth factor receptor-2 (HER2) amplification and brain metastasis (BM) in patients having colorectal cancer (CRC) has been suggested but not yet established. This study investigated the expression patterns of HER2, its association with BM, and its prognostic value in patients having CRC. We retrospectively identified 99 patients having metastatic CRC (mCRC) and BM (the BM cohort) and compared them with a cohort of 249 patients having mCRC and without BM (the stage IV cohort) by propensity score matching. Immunohistochemical studies of HER2 on all available paraffin-embedded tumour samples, either from the primary tumour, the metastasis (brain and/or extracranial sites) or both, were performed and analysed. HER2 fluorescent in situ hybridisation was applied when necessary. The expression of HER2 was compared and correlated with survival. HER2 amplifications were detected in 16 (18.4%) of 87 and 9 (3.6%) of 249 patients who had specimens available in the BM and stage IV cohorts, respectively (P <.001). After propensity score matching, HER2 amplification was significantly associated with BM (odds ratio: 5.38, P =.003). HER2 heterogeneity was frequently observed not only at the single tumour level but also in paired tumour samples. A marginally significant longer survival since BM was found in patients having HER2-amplified mCRC than in those without (P =.07). HER2 amplification was significantly associated with BM in patients having mCRC and might have prognostic value for survival since BM. Given the heterogeneity of HER2 expression, the testing of HER2 status on available tissues from both primary and metastatic tumours should be encouraged. • Propensity score matching examined HER2 amplification and brain metastases. • High frequency of HER2 amplification in patients having metastatic colorectal cancer and brain metastasis was demonstrated. • Intra-patient heterogeneities of HER2 amplification were observed. [ABSTRACT FROM AUTHOR]

Background: Nitric oxide-releasing drugs are used for cardiovascular diseases; however, their effects on the tumor immune microenvironment are less clear. Therefore, this study explored the impact of nitric oxide donors on tumor progression in immune-competent mice. Methods: The effects of three different nitric oxide-releasing compounds (SNAP, SNP, and ISMN) on tumor growth were studied in tumor-bearing mouse models. Three mouse tumor models were used: B16F1 melanoma and LL2 lung carcinoma in C57BL/6 mice, CT26 colon cancer in BALB/c mice, and LL2 lung carcinoma in NOD/SCID mice. After nitric oxide treatment, splenic cytokines and lymphocytes were analyzed by cytokine array and flow cytometry, and tumor-infiltrating lymphocytes in the TME were analyzed using flow cytometry and single-cell RNA sequencing. Results: Low doses of three exogenous nitric oxide donors inhibited tumor growth in two immunocompetent mouse models but not in NOD/SCID immunodeficient mice. Low-dose nitric oxide donors increase the levels of splenic cytokines IFN-γ and TNF-α but decrease the levels of cytokines IL-6 and IL-10, suggesting an alteration in Th2 cells. Nitric oxide donors increased the number of CD8+ T cells with activation gene signatures, as indicated by single-cell RNA sequencing. Flow cytometry analysis confirmed an increase in infiltrating CD8+ T cells and dendritic cells. The antitumor effect of nitric oxide donors was abolished by depletion of CD8+ T cells, indicating the requirement for CD8+ T cells. Tumor inhibition correlated with a decrease in a subtype of protumor macrophages and an increase in a subset of Arg1-positive macrophages expressing antitumor gene signatures. The increase in this subset of macrophages was confirmed by flow cytometry analysis. Finally, the combination of low-dose nitric oxide donor and cisplatin induced an additive cancer therapeutic effect in two immunocompetent animal models. The enhanced therapeutic effect was accompanied by an increase in the cells expressing the gene signature of NK cell. Conclusions: Low concentrations of exogenous nitric oxide donors inhibit tumor growth in vivo by regulating T cells and macrophages. CD8+ T cells are essential for antitumor effects. In addition, low-dose nitric oxide donors may be combined with chemotherapeutic drugs in cancer therapy in the future. [ABSTRACT FROM AUTHOR]

This study aimed to assess the impact of diabetic retinopathy (DR) severity on the incidence of major adverse cardiac events (MACE) and end-stage renal disease (ESRD) in T1D patients. Patients diagnosed with T1D between 1999 and 2013 were identified from patient-level data of Taiwan's National Health Insurance Research database. A total of 1135 patients were included and classified into mild DR (n = 454), severe DR (n = 227), or non-DR (n = 454) by using propensity score matching. Multi-state model analyses, an extension of competing risk models with adjustment for transition-specific covariates for prediction of subsequent MACE and ESRD, were performed. MACE and ESRD risks were significantly higher in the severe DR patients; a 2.97-fold (1.73, 5.07) and 12.29-fold (6.50, 23.23) increase in the MACE risk among the severe DR patients compared to the mild DR and DR-free patients, respectively; and, a 5.91-fold (3.50, 9.99) and 82.31-fold (29.07, 233.04) greater ESRD risk of severe DR patients than that of the mild DR and DR-free groups, respectively (p < 0.001). Severity of DR was significantly associated with the late diabetes-related vascular events (i.e., MACE, ESRD) among T1D patients. [ABSTRACT FROM AUTHOR]

Background: The impact of sagittal spinopelvic alignment on spondylolysis is well established in Caucasian populations. However, prior studies suggest that people from different ethnological backgrounds showed divergence, and a few studies that focused on Asian populations reported conflicting results. The aim of this study is to use the EOS imaging system to evaluate the spinopelvic parameters of spondylolysis patients, and their relationship with spondylolisthesis, disc degeneration, and age in a Taiwanese population.Methods: Radiographic sagittal spinopelvic parameters for 45 spondylolysis patients and 32 healthy people were evaluated, including pelvic incidence (PI), sacral slope (SS), pelvic tilt (PT), thoracic kyphosis (TK), and lumbar lordosis (LL). The spinopelvic parameters were compared between spondylolytic and control groups. These parameters were further compared between spondylolytic subjects with and without spondylolisthesis, with and without high-grade disc degeneration, and young (< 30 years old) and middle-aged.Results: The PI and LL of the spondylolytic group (52.6°±12.0° and 41.3°±15.2°) were significantly higher than those of the healthy control group (47.16°±7.95° and 28.22°±10.65°). Further analysis of the spondylolytic patients revealed that those with high-grade disc degeneration were more prone to spondylolisthesis (92.3 %) compared to those without (50 %; p = 0.001). The middle-aged group had significantly higher rates of spondylolisthesis (80 %) and high-grade disc degeneration (52.4 %) compared with those for the young group (45 and 16.7 %, respectively; p = 0.017 and 0.047, respectively). No statistically significant difference in the sagittal spinopelvic parameters was found when spondylolytic patients were divided according to the occurrence of spondylolisthesis or high-grade disc degeneration.Conclusions: In a Taiwanese population, PI and LL were significantly larger in spondylolytic patients. Disc degeneration and age were associated with the occurrence of spondylolisthesis. Ethnological differences should thus be taken into account when making clinical decisions regarding spondylolysis in a Taiwanese population. [ABSTRACT FROM AUTHOR]

Premature atrial complexes (PACs) have been suggested to increase the risk of adverse events. The distribution of PAC burden and its dose–response effects on all-cause mortality and cardiovascular death had not been elucidated clearly. We analyzed 15,893 patients in a medical referral center from July 1st, 2011, to December 31st, 2018. Multivariate regression driven by ln PAC (beats per 24 h plus 1) or quartiles of PAC burden were examined. Older group had higher PAC burden than younger group (p for trend < 0.001), and both genders shared similar PACs distribution. In Cox model, ln PAC remained an independent risk factor for all-cause mortality (hazard ratio (HR) = 1.09 per ln PAC increase, 95% CI = 1.06‒1.12, p < 0.001). PACs were a significant risk factor in cause-specific model (HR = 1.13, 95% CI = 1.05‒1.22, p = 0.001) or sub-distribution model (HR = 1.12, 95% CI = 1.04‒1.21, p = 0.004). In ordinal PAC model, 4th quartile group had significantly higher risk of all-cause mortality than those in 1st quartile group (HR = 1.47, 95% CI = 1.13‒1.94, p = 0.005), but no difference in cardiovascular death were found in competing risk analysis. In subgroup analysis, the risk of high PAC burden was consistently higher than in low-burden group across pre-specified subgroups. In conclusion, PAC burden has a dose response effect on all-cause mortality and cardiovascular death. [ABSTRACT FROM AUTHOR]