scholarly journals Detection of Unknown Ototoxic Adverse Drug Reactions: An Electronic Healthcare Record-Based Longitudinal Nationwide Cohort Analysis

2021 ◽  
Author(s):  
Suehyun Lee ◽  
Jaehun Cha ◽  
Jong-Yeup Kim ◽  
Gil Myeong Son ◽  
Dong-Kyu Kim
Keyword(s):  
Hearing Loss ◽  
Adverse Drug Reactions ◽  
Proportional Hazards ◽  
Cohort Analysis ◽  
Cox Proportional Hazards ◽  
Hazard Ratio ◽  
New Drugs ◽  
Rank Test ◽  
Drug Reactions ◽  
Bilateral Hearing Loss

Abstract Ototoxic medications can lead to significant morbidity. Thus, pre-marketing clinical trials have assessed new drugs that have ototoxic potential. Nevertheless, several ototoxic side effects of drugs may remain undetected. Hence, we sought to retrospectively investigate the potential risk of ototoxic adverse drug reactions among commonly used drugs via a longitudinal cohort study. An electronic health records-based data analysis with a propensity-matched comparator group was carried out. This study was conducted using the MetaNurse algorithm for standard nursing statements on electronic healthcare records and the National Sample Cohort obtained from the South Korea National Health Insurance Service. Five target drugs capable of causing ototoxic adverse drug reactions were identified using MetaNurse; two drugs were excluded after database-based analysis because of the absence of bilateral hearing loss events in patients. Survival analysis, log-rank test, and Cox proportional hazards regression models were used to calculate the incidence, survival rate, and hazard ratio of bilateral hearing loss among patients who were prescribed candidate ototoxic drugs. The adjusted hazard ratio of bilateral hearing loss was 1.31 (1.03–1.68), 2.20 (1.05–4.60), and 2.26 (1.18–4.33) in cimetidine, hydroxyzine, and sucralfate users, respectively. Our results indicated that hydroxyzine and sucralfate may cause ototoxic adverse drug reactions in patients. Thus, clinicians should consider the risk of ototoxicity when prescribing these drugs.

scholarly journals Detection of unknown ototoxic adverse drug reactions: an electronic healthcare record-based longitudinal nationwide cohort analysis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Suehyun Lee ◽  
Jaehun Cha ◽  
Jong-Yeup Kim ◽  
Gil Myeong Son ◽  
Dong-Kyu Kim
Keyword(s):  
Hearing Loss ◽  
Adverse Drug Reactions ◽  
Cohort Analysis ◽  
Cox Proportional Hazards ◽  
Hazard Ratio ◽  
New Drugs ◽  
Rank Test ◽  
Drug Reactions ◽  
Bilateral Hearing Loss ◽  
Ototoxic Drugs

AbstractOtotoxic medications can lead to significant morbidity. Thus, pre-marketing clinical trials have assessed new drugs that have ototoxic potential. Nevertheless, several ototoxic side effects of drugs may remain undetected. Hence, we sought to retrospectively investigate the potential risk of ototoxic adverse drug reactions among commonly used drugs via a longitudinal cohort study. An electronic health records-based data analysis with a propensity-matched comparator group was carried out. This study was conducted using the MetaNurse algorithm for standard nursing statements on electronic healthcare records and the National Sample Cohort obtained from the South Korea National Health Insurance Service. Five target drugs capable of causing ototoxic adverse drug reactions were identified using MetaNurse; two drugs were excluded after database-based analysis because of the absence of bilateral hearing loss events in patients. Survival analysis, log-rank test, and Cox proportional hazards regression models were used to calculate the incidence, survival rate, and hazard ratio of bilateral hearing loss among patients who were prescribed candidate ototoxic drugs. The adjusted hazard ratio of bilateral hearing loss was 1.31 (1.03–1.68), 2.20 (1.05–4.60), and 2.26 (1.18–4.33) in cimetidine, hydroxyzine, and sucralfate users, respectively. Our results indicated that hydroxyzine and sucralfate may cause ototoxic adverse drug reactions in patients. Thus, clinicians should consider avoiding co-administration of these drugs with other well-confirmed ototoxic drugs should be emphasized.

Impact of Cognitive Dysfunction on Survival in Patients With and Without Statin Use Following Carotid Endarterectomy

Neurosurgery ◽  
2015 ◽  
Vol 77 (6) ◽  
pp. 880-887 ◽  
Author(s):  
Eric J. Heyer ◽  
Joanna L. Mergeche ◽  
Shuang Wang ◽  
John G. Gaudet ◽  
E. Sander Connolly
Keyword(s):  
Confidence Interval ◽  
Carotid Endarterectomy ◽  
Cognitive Dysfunction ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
Hazard Ratio ◽  
Rank Test ◽  
Term Survival ◽  
Asymptomatic Patients ◽  
Statin Use

BACKGROUND: Early cognitive dysfunction (eCD) is a subtle form of neurological injury observed in ∼25% of carotid endarterectomy (CEA) patients. Statin use is associated with a lower incidence of eCD in asymptomatic patients having CEA. OBJECTIVE: To determine whether eCD status is associated with worse long-term survival in patients taking and not taking statins. METHODS: This is a post hoc analysis of a prospective observational study of 585 CEA patients. Patients were evaluated with a battery of neuropsychometric tests before and after surgery. Survival was compared for patients with and without eCD stratifying by statin use. At enrollment, 366 patients were on statins and 219 were not. Survival was assessed by using Kaplan-Meier methods and multivariable Cox proportional hazards models. RESULTS: Age ≥75 years (P = .003), diabetes mellitus (P < .001), cardiac disease (P = .02), and statin use (P = .014) are significantly associated with survival univariately (P < .05) by use of the log-rank test. By Cox proportional hazards model, eCD status and survival adjusting for univariate factors within statin and nonstatin use groups suggested a significant effect by association of eCD on survival within patients not taking statin (hazard ratio, 1.61; 95% confidence interval, 1.09–2.40; P = .018), and no significant effect of eCD on survival within patients taking statin (hazard ratio, 0.98; 95% confidence interval, 0.59–1.66; P = .95). CONCLUSION: eCD is associated with shorter survival in patients not taking statins. This finding validates eCD as an important neurological outcome and suggests that eCD is a surrogate measure for overall health, comorbidity, and vulnerability to neurological insult.

scholarly journals Association of Rehabilitation Intensity for Stroke and Risk of Hospital Readmission

2015 ◽  
Vol 95 (12) ◽  
pp. 1660-1667 ◽  
Author(s):  
A. Williams Andrews ◽  
Dongmei Li ◽  
Janet K. Freburger
Keyword(s):  
Confidence Interval ◽  
Acute Care ◽  
Hospital Readmission ◽  
Proportional Hazards ◽  
Cohort Analysis ◽  
Hospital Readmissions ◽  
Illness Severity ◽  
Cox Proportional Hazards ◽  
Hazard Ratio ◽  
Increased Risk

Background Little is known about the use of rehabilitation in the acute care setting and its impact on hospital readmissions. Objective The objective of this study was to examine the association between the intensity of rehabilitation services received during the acute care stay for stroke and the risk of 30-day and 90-day hospital readmission. Design A retrospective cohort analysis of all acute care hospitals in Arkansas and Florida was conducted. Methods Patients (N=64,065) who were admitted for an incident stroke in 2009 or 2010 were included. Rehabilitation intensity was categorized as none, low, medium-low, medium-high, or high based on the sum and distribution of physical therapy, occupational therapy, and speech therapy charges within each hospital. Cox proportional hazards regression was used to estimate hazard ratios, controlling for demographic characteristics, illness severity, comorbidities, hospital variables, and state. Results Relative to participants who received the lowest intensity therapy, those who received higher-intensity therapy had a decreased risk of 30-day readmission. The risk was lowest for the highest-intensity group (hazard ratio=0.86; 95% confidence interval=0.79, 0.93). Individuals who received no therapy were at an increased risk of hospital readmission relative to those who received low-intensity therapy (hazard ratio=1.30; 95% confidence interval=1.22, 1.40). The findings were similar, but with smaller effects, for 90-day readmission. Furthermore, patients who received higher-intensity therapy had more comorbidities and greater illness severity relative to those who received lower-intensity therapy. Limitations The results of the study are limited in scope and generalizability. Also, the study may not have adequately accounted for all potentially important covariates. Conclusions Receipt of and intensity of rehabilitation therapy in the acute care of stroke is associated with a decreased risk of hospital readmission.

Association of co-medication quality with chemotherapy-related adverse drug reactions and survival in older colorectal cancer patients

2021 ◽  
Author(s):  
Li-Ju Chen ◽  
Thi Ngoc Mai Nguyen ◽  
Dana Clarissa Laetsch ◽  
Jenny Chang-Claude ◽  
Michael Hoffmeister ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Cancer Patients ◽  
Adverse Drug Reactions ◽  
Proportional Hazards ◽  
Inappropriate Medication ◽  
Medication Management ◽  
Cox Proportional Hazards ◽  
Potentially Inappropriate Medication ◽  
Drug Reactions ◽  
Logistic Regression Models

Abstract Background Evidence about the clinical relevance of appropriate co-medication among older colorectal cancer (CRC) patients is sparse. Methods A cohort study was conducted with 3,239 CRC patients aged 65 years and older. To assess co-medication quality, we calculated the total Fit fOR The Aged (FORTA) score and its sub-scores for medication overuse, underuse, and potentially inappropriate medication use. Multivariable Cox proportional hazards or logistic regression models were performed to evaluate the association of co-medication quality with up to 5-year overall survival, CRC-specific survival, and chemotherapy-related adverse drug reactions (ADRs). Results Overall, 3,239 and 1,209 participants were included in analyses on survival and ADRs, respectively. The hazard ratios [95%-confidence intervals] for the total FORTA score ≥ 7 vs. 0-1 points were 1.83 [1.40-2.40] and 1.76 [1.22-2.52] for up to 5-year overall and CRC-specific survival, respectively. Worse up to 5-year OS and CSS was also evident for FORTA sub-scores for PIM use and overuse whereas no association was observed for underuse. Although results for the total FORTA and potentially inappropriate medication score were much stronger among patients receiving chemotherapy, no significant associations with chemotherapy-related ADRs were observed. Moreover, associations were particularly strong among men and rectal cancer patients as compared to women and colon cancer patients. Conclusions Poor total co-medication quality was significantly associated with worse up to 5-year overall and CRC-specific survival. Randomized controlled trials are needed to test whether improved cancer co-medication management in older CRC patients prolongs survival.

scholarly journals Effect of Ranitidine Intake on the Risk of Gastric Cancer Development

Healthcare ◽  
2021 ◽  
Vol 9 (8) ◽  
pp. 1071
Author(s):  
SunMoon Kim ◽  
Suehyun Lee ◽  
JeeYoung Hong ◽  
Inseok Ko ◽  
Jong-Yeup Kim ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Proportional Hazards ◽  
Sociodemographic Factors ◽  
Cox Proportional Hazards ◽  
Hazard Ratio ◽  
Cancer Development ◽  
Rank Test ◽  
Potential Association ◽  
Korean National Health Insurance

Gastric cancer is one of the most prevalent cancers globally, with high mortality, particularly in East Asia. Certain ranitidine products contain potentially carcinogenic N-nitrosodimethylamine. We investigated the potential association between gastric cancer risk and ranitidine intake using a nationwide cohort, extracted from the Korean National Health Insurance Service. In this longitudinal study, we employed a 1:1 propensity score matching according to sociodemographic factors. A total of 40,887 subjects were enrolled, of which 906 developed gastric cancer during the follow-up period. We investigated gastric cancer events during the follow-up period using the survival analysis, log-rank test, and Cox proportional hazards regression models to estimate incidence, survival rate, and hazard ratio. The incidence of gastric cancer was 67,422; 67,470; and 67,444 person-years in the control, other histamine-2 blockers, and ranitidine groups, respectively. Because the adjusted hazard ratio of gastric cancer was 0.98 and 1.01 in the other histamine-2 blockers and ranitidine groups, respectively, we could not calculate the likelihood of gastric cancer development in the ranitidine group. Ranitidine intake did not significantly increase the incidence of gastric cancer. Therefore, the relative risk of gastric cancer may be low in patients taking ranitidine products in South Korea.

scholarly journals Kawasaki Disease Increases the Incidence of Myopia

2017 ◽  
Vol 2017 ◽  
pp. 1-6 ◽  
Author(s):  
Yung-Jen Kung ◽  
Chang-Ching Wei ◽  
Liuh An Chen ◽  
Jiin Yi Chen ◽  
Ching-Yao Chang ◽  
...  
Keyword(s):  
Kawasaki Disease ◽  
Regression Model ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
Hazard Ratio ◽  
Health Concern ◽  
Rank Test ◽  
Research Database ◽  
Cox Proportional Hazards Regression ◽  
Proportional Hazards Regression

The prevalence of myopia has rapidly increased in recent decades and has led to a considerable global public health concern. In this study, we elucidate the relationship between Kawasaki disease (KD) and the incidence of myopia. We used Taiwan’s National Health Insurance Research Database to conduct a population-based cohort study. We identified patients diagnosed with KD and individuals without KD who were selected by frequency matched based on sex, age, and the index year. The Cox proportional hazards regression model was used to estimate the hazard ratio and 95% confidence intervals for the comparison of the 2 cohorts. The log-rank test was used to test the incidence of myopia in the 2 cohorts. A total of 532 patients were included in the KD cohort and 2128 in the non-KD cohort. The risk of myopia (hazard ratio, 1.31; 95% confidence interval, 1.08–1.58; P<0.01) was higher among patients with KD than among those in the non-KD cohort. The Cox proportional hazards regression model showed that irrespective of age, gender, and urbanization, Kawasaki disease was an independent risk factor for myopia. Patients with Kawasaki disease exhibited a substantially higher risk for developing myopia.

Factors that contribute to urban–rural gradients in risk of schizophrenia: Comparing Danish and Western Australian registers

2021 ◽  
pp. 000486742110096
Author(s):  
Oleguer Plana-Ripoll ◽  
Patsy Di Prinzio ◽  
John J McGrath ◽  
Preben B Mortensen ◽  
Vera A Morgan
Keyword(s):  
Confidence Interval ◽  
Western Australia ◽  
Urban Areas ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
Hazard Ratio ◽  
Indigenous Status ◽  
Increased Risk ◽  
The Relationship ◽  
Western Australian

Introduction: An association between schizophrenia and urbanicity has long been observed, with studies in many countries, including several from Denmark, reporting that individuals born/raised in densely populated urban settings have an increased risk of developing schizophrenia compared to those born/raised in rural settings. However, these findings have not been replicated in all studies. In particular, a Western Australian study showed a gradient in the opposite direction which disappeared after adjustment for covariates. Given the different findings for Denmark and Western Australia, our aim was to investigate the relationship between schizophrenia and urbanicity in these two regions to determine which factors may be influencing the relationship. Methods: We used population-based cohorts of children born alive between 1980 and 2001 in Western Australia ( N = 428,784) and Denmark ( N = 1,357,874). Children were categorised according to the level of urbanicity of their mother’s residence at time of birth and followed-up through to 30 June 2015. Linkage to State-based registers provided information on schizophrenia diagnosis and a range of covariates. Rates of being diagnosed with schizophrenia for each category of urbanicity were estimated using Cox proportional hazards models adjusted for covariates. Results: During follow-up, 1618 (0.4%) children in Western Australia and 11,875 (0.9%) children in Denmark were diagnosed with schizophrenia. In Western Australia, those born in the most remote areas did not experience lower rates of schizophrenia than those born in the most urban areas (hazard ratio = 1.02 [95% confidence interval: 0.81, 1.29]), unlike their Danish counterparts (hazard ratio = 0.62 [95% confidence interval: 0.58, 0.66]). However, when the Western Australian cohort was restricted to children of non-Aboriginal Indigenous status, results were consistent with Danish findings (hazard ratio = 0.46 [95% confidence interval: 0.29, 0.72]). Discussion: Our study highlights the potential for disadvantaged subgroups to mask the contribution of urban-related risk factors to risk of schizophrenia and the importance of stratified analysis in such cases.

scholarly journals Epilepsy as a Comorbidity in Polymyositis and Dermatomyositis—A Cross-Sectional Study

2021 ◽  
Vol 18 (8) ◽  
pp. 3983
Author(s):  
Ella Nissan ◽  
Abdulla Watad ◽  
Arnon D. Cohen ◽  
Kassem Sharif ◽  
Johnatan Nissan ◽  
...  
Keyword(s):  
Proportional Hazards ◽  
Cross Sectional Study ◽  
Cox Proportional Hazards ◽  
Categorical Variables ◽  
Rank Test ◽  
Control Group ◽  
Multivariable Logistic Regression Analysis ◽  
Positive Trend ◽  
Continuous Variables ◽  
Cross Sectional

Polymyositis (PM) and dermatomyositis (DM) are autoimmune-mediated multisystemic myopathies, characterized mainly by proximal muscle weakness. A connection between epilepsy and PM/DM has not been reported previously. Our study aim is to evaluate this association. A case–control study was conducted, enrolling a total of 12,278 patients with 2085 cases (17.0%) and 10,193 subjects in the control group (83.0%). Student’s t-test was used to evaluate continuous variables, while the chi-square test was applied for the distribution of categorical variables. Log-rank test, Kaplan–Meier curves and multivariate Cox proportional hazards method were performed for the analysis regarding survival. Of the studied 2085 cases, 1475 subjects (70.7%) were diagnosed with DM, and 610 patients (29.3%) with PM. Participants enrolled as cases had a significantly higher rate of epilepsy (n = 48 [2.3%]) as compared to controls (n = 141 [1.4%], p < 0.0005). Using multivariable logistic regression analysis, PM was found only to be significantly associated with epilepsy (OR 2.2 [95%CI 1.36 to 3.55], p = 0.0014), whereas a non-significant positive trend was noted in DM (OR 1.51 [95%CI 0.99 to 2.30], p = 0.0547). Our data suggest that PM is associated with a higher rate of epilepsy compared to controls. Physicians should be aware of this comorbidity in patients with immune-mediated myopathies.

scholarly journals Influence of Smoking Habits on the Prevalence of Dental Caries: A Register-Based Cohort Study

2021 ◽  
Author(s):  
Miguel A. de Araújo Nobre ◽  
Ana M. Sezinando ◽  
Inês C. Fernandes ◽  
Andreia C. Araújo
Keyword(s):  
Dental Caries ◽  
Proportional Hazards ◽  
Smoking Habit ◽  
Cox Proportional Hazards ◽  
Radiographic Examination ◽  
Rank Test ◽  
Significance Level ◽  
Cumulative Survival ◽  
Caries Lesions

Abstract Objective The study aimed to evaluate the influence of smoking habit on the prevalence of dental caries lesions in a follow-up study. Materials and Methods A total of 3,675 patients (2,186 females and 1,489 males) with an average age of 51.4 years were included. Outcome measures were the incidence of dental caries defined as incipient noncavitated, microcavitated, or cavitated lesions which had been diagnosed through clinical observation with mouth mirror and probe examination evaluating change of texture, translucency, and color; radiographic examination through bitewing radiographs; or secondary caries through placement of a new restoration during the follow-up of the study. Statistical Analysis Cumulative survival (time elapsed with absence of dental caries) was estimated through the Kaplan–Meier product limit estimator with comparison of survival curves (log-rank test). A multivariable Cox proportional hazards regression model was used to evaluate the effect of smoking on the incidence of dental caries lesions when controlled to age, gender, systemic status, frequency of dental hygiene appointments, and socioeconomic status. The significance level was set at 5%. Results Eight hundred sixty-three patients developed caries (23.5% incidence rate). The cumulative survival estimation was 81.8% and 48% survival rate for nonsmokers and smokers, respectively (p < 0.001), with an average of 13.5 months between the healthy and diseased state diagnosis. Smokers registered a hazard ratio for dental caries lesions of 1.32 (p = 0.001) when controlled for the other variables of interest. Conclusion Within the limitations of this study, it was concluded that smoking habit might be a predictor for dental caries.

The Efficacy of Etoposide-Based Therapy in Adult Secondary Hemophagocytic Lymphohistiocytosis

2021 ◽  
pp. 1-9
Author(s):  
Leonard Naymagon ◽  
Douglas Tremblay ◽  
John Mascarenhas
Keyword(s):  
Hemophagocytic Lymphohistiocytosis ◽  
Proportional Hazards ◽  
Multivariable Analysis ◽  
Cox Proportional Hazards ◽  
Rank Test ◽  
Kaplan Meier ◽  
Hazard Ratios ◽  
Significant Difference ◽  
The Impact

Data supporting the use of etoposide-based therapy in hemophagocytic lymphohistiocytosis (HLH) arise largely from pediatric studies. There is a lack of comparable data among adult patients with secondary HLH. We conducted a retrospective study to assess the impact of etoposide-based therapy on outcomes in adult secondary HLH. The primary outcome was overall survival. The log-rank test was used to compare Kaplan-Meier distributions of time-to-event outcomes. Multivariable Cox proportional hazards modeling was used to estimate adjusted hazard ratios (HRs) with 95% confidence intervals (CIs). Ninety adults with secondary HLH seen between January 1, 2009, and January 6, 2020, were included. Forty-two patients (47%) received etoposide-based therapy, while 48 (53%) received treatment only for their inciting proinflammatory condition. Thirty-three patients in the etoposide group (72%) and 32 in the no-etoposide group (67%) died during follow-up. Median survival in the etoposide and no-etoposide groups was 1.04 and 1.39 months, respectively. There was no significant difference in survival between the etoposide and no-etoposide groups (log-rank <i>p</i> = 0.4146). On multivariable analysis, there was no association between treatment with etoposide and survival (HR for death with etoposide = 1.067, 95% CI: 0.633–1.799, <i>p</i> = 0.8084). Use of etoposide-based therapy was not associated with improvement in outcomes in this large cohort of adult secondary HLH patients.

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