scholarly journals Response to “The Self‐Controlled Case Series Design as a Viable Alternative to Studying Clinically Relevant Drug Interactions”

2019 ◽  
Vol 107 (2) ◽  
pp. 323-323 ◽  
Author(s):  
Katsiaryna Bykov ◽  
Joshua J. Gagne
2019 ◽  
Vol 107 (2) ◽  
pp. 321-322 ◽  
Author(s):  
Meijia Zhou ◽  
Charles E. Leonard ◽  
Warren B. Bilker ◽  
Sean Hennessy

Circulation ◽  
2018 ◽  
Vol 138 (4) ◽  
pp. 356-363 ◽  
Author(s):  
Tzu-Ting Chen ◽  
Yi-Chun Yeh ◽  
Kuo-Liong Chien ◽  
Mei-Shu Lai ◽  
Yu-Kang Tu

Background: Invasive dental treatments (IDTs) can yield temporary bacteremia and have therefore been considered a potential risk factor of infective endocarditis (IE). It is hypothesized that, through the trauma caused by IDTs, bacteria gain entry to the bloodstream and may attach to abnormal heart valves or damaged heart tissue, giving rise to IE. However, the association between IDTs and IE remains controversial. The aim of this study is to estimate the association between IDTs and IE. Methods: The data in this study were obtained from the Health Insurance Database in Taiwan. We selected 2 case-only study designs, case-crossover and self-controlled case series, to analyze the data. The advantage of these methods is that confounding factors that do not vary with time are adjusted for implicitly. In the case-crossover design, a conditional logistic regression model with exposure to IDTs was used to estimate the risks of IE following an IDT with 4, 8, 12, and 16 weeks delay, respectively. In the self-controlled case series design, a conditional Poisson regression model was used to estimate the risk of IE for the risk periods of 1 to 4, 5 to 8, 9 to 12, and 13 to 16 weeks following an IDT. Results: In total, 9120 and 8181 patients with IE were included in case-crossover design and self-controlled case series design, respectively. In the case-crossover design, 277 cases and 249 controls received IDTs during the exposure period, and the odds ratio was 1.12 (95% confidence interval, 0.94–1.34) for 4 weeks. In the self-controlled case series design, we observed that 407 IEs occurred during the first 4 weeks after IDTs, and the age-adjusted incidence rate ratio was 1.14 (95% confidence interval, 1.02–1.26) for 1 to 4 weeks after IDTs. Conclusions: In both study designs, we did not observe a clinically larger risk for IE in the short periods after IDTs. We also found no association between IDTs and IE among patients with a high risk of IE. Therefore, antibiotic prophylaxis for the prevention of IE is not required for the Taiwanese population.


Drug Safety ◽  
2013 ◽  
Vol 36 (S1) ◽  
pp. 83-93 ◽  
Author(s):  
Marc A. Suchard ◽  
Ivan Zorych ◽  
Shawn E. Simpson ◽  
Martijn J. Schuemie ◽  
Patrick B. Ryan ◽  
...  

2019 ◽  
Author(s):  
David John Hallford ◽  
Manoj Kumar Sharma ◽  
David W. Austin

Depressed individuals have difficulty anticipating pleasure, which can impact motivation and functioning. One factor in this may be impairments in their episodic future thinking (EFT). This study examined whether enhancing EFT through increasing detail/vividness and mental imagery would increase anticipatory pleasure among individuals with Major Depressive Disorder. A randomized start-point, single case series design was used. Depressed outpatients (N = 7) completed surveys through the day over two weeks to nominate upcoming positive events and rate them on EFT detail/vividness, mental imagery, and anticipatory pleasure. At a randomized start-point, activities to enhance the detail/vividness and mental imagery for these upcoming events were introduced. Significant increases in detail and imagery were observed when EFT activities were introduced, which correlated with increases in how pleasurable it was thought the activities would be and how pleasurable it was thinking about them. Enhancing EFT may be a mechanism to increase anticipatory pleasure in depression. Implications for treatment are discussed.


2018 ◽  
pp. 1-4
Author(s):  
Dignan Mark ◽  
Dignan Mark ◽  
Kitzman Patrick ◽  
S Gutti Subhash ◽  
N Gutti Swathi ◽  
...  

This project used a retrospective case series design to investigate factors associated with stroke in a rural area in Appalachian Kentucky. The south-eastern region of the U.S. is often referred to as the ‘stroke belt,’ and includes the Appalachian region of the state of Kentucky. Data were collected from medical records of patients from a neurology practice and regional hospital with a diagnosis of stroke from March 2012 through November 2015. Data were collected without personal identifiers and included demographic characteristics, stroke type, treatments received, and referrals for additional care including rehabilitation. Data from a total of 84 stroke cases diagnosed between March 2012 and November 2015 were included. Of the 84 cases, 46 (54.8%) were female and all but one was Caucasian. The distribution by race is consistent with the population of the region. The stroke cases ranged in age from 41 to 92 (M=66.3) and the age at stroke diagnosis ranged from 40 to 90 (M=65.7). Fourteen (16.7%) had evidence of a previous stroke at diagnosis. For smokers, the mean age at diagnosis was 62.7 for smokers while for non-smokers it was 67.5. The study reported smoking rates that were nearly three-times the national average, and the smokers in this study were found to have stroke onset approximately five-years earlier than non-smokers. The results from this case series support the need for further investigation on stroke prevalence and factors contributing to continued risk for stroke in Appalachia.


SLEEP ◽  
2019 ◽  
Vol 43 (3) ◽  
Author(s):  
Hyewon Kim ◽  
Yuwon Kim ◽  
Woojae Myung ◽  
Maurizio Fava ◽  
David Mischoulon ◽  
...  

Abstract Objectives To investigate the association between zolpidem prescription and suicide attempts in people with depression Methods A nationwide, population-based electronic medical records database from the Health Insurance Review & Assessment Service of South was used to investigate the incidence rate ratios (IRRs) of suicide attempts and probable suicide attempts in people with depression before and after zolpidem prescription using self-controlled case series design. Results In a total of 445 people who attempted suicide and 23 141 people who attempted probable suicide attempt, the IRRs of suicidal behavior during the risk periods before and after zolpidem prescription increased compared with those at the baseline. The IRRs gradually increased and peaked immediately before the prescription of zolpidem. The IRR was 70.06 (95% CI: 25.58–191.90) on day 2 before zolpidem prescription and 63.35 (95% CI: 22.99–174.59) on day 1 after zolpidem prescription in the suicide attempt group. The IRR was 24.07 (95% CI: 20.50–28.26) on the day before zolpidem prescription and 14.96 (95% CI: 12.21–18.34) on the day after zolpidem prescription in the probable suicide attempt group. The ratios declined eventually after zolpidem was prescribed. Conclusions Although zolpidem prescription was associated with an increased risk of suicide attempts in people with depression, the risk increased and peaked immediately before zolpidem prescription. The risk declined gradually thereafter. This result indicates that the risk of suicide attempts increases at the time of zolpidem prescription. However, zolpidem prescription does not contribute to additional increase in the risk of suicide attempts.


2019 ◽  
Vol 35 (1) ◽  
pp. 55-74
Author(s):  
Katrina Nicholas ◽  
Mary Alt ◽  
Ella Hauwiller

The purpose of this study was to investigate the role of variability in teaching prepositions to preschoolers with typical development (TD) and developmental language disorder (DLD). Input variability during teaching can enhance learning, but is target dependent. We hypothesized that high variability of objects would improve preposition learning. We also examined other characteristics (e.g. vocabulary skills) of children who responded to treatment. We used a case series design, repeated across children ( n = 18) to contrast how preschoolers learned prepositions in conditions that manipulated variability of objects and labels across three treatment sessions. We contrasted a high versus low variability condition for objects and labels for one group of typically-developing (TD) children ( n = 6). In other groups (TD, n = 6; DLD, n = 6), we contrasted high versus low object variability only. Visual inspection and descriptive statistics were used to characterize gains. Half ( n = 3) of TD participants showed a low variability advantage for the condition that combined object and label variability. In the condition that only contrasted object variability, the majority ( n = 4) of TD participants showed a high variability advantage, compared to only two participants with DLD. In the high object variability condition, high receptive vocabulary scores were significantly correlated with high performance of learning prepositions ( rs = 0.71, p < 0.05). Combining high variability for objects and labels when teaching prepositions was not effective. However, high variability for objects can create a learning advantage for learning prepositions for children with typically developing language, but not all learners. Characteristics of different learners (e.g. receptive vocabulary scores) and language status (impaired or unimpaired) should be taken into consideration for future studies.


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