Toshiharu Mitsuhashi

Evaluation of an internet-based self-help program for better quality of sleep among Japanese workers: a randomized controlled trial.

Evaluation of an Internet‐Based Self‐Help Program for Better Quality of Sleep among Japanese Workers: A Randomized Controlled Trial: Etsuji Suzuki, et al. Department of Epidemiology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences—The effectiveness of Internet‐based self‐help programs for insomnia is still unclear. A randomized controlled trial was conducted to evaluate the effect of an Internet‐based self‐help program for better quality of sleep among adult workers. Forty‐three volunteers were recruited and randomly assigned to either an intervention group (n=21) or a waiting‐list group (n=22). The intervention group participated in a two‐week Internet‐based program, including selecting and daily practicing sleep‐related target behaviors and monitoring those behaviors along with sleep quality. At the same time, each participant received automatically generated, personalized messages and reports both daily and weekly. A total of 12 intervention group participants and 18 waiting‐list group participants completed questionnaires at baseline, post‐intervention, and at a 3‐wk follow‐up. Subjective sleep quality was measured by a self‐reported questionnaire developed for this study. The sleep quality score increased in the intervention group at post‐intervention, with a significant interaction effect [F(1,28)=5.19, p=0.031]. Sleep‐related behaviors also greatly increased in the intervention group at post‐intervention, with a significant interaction effect [F(1,28)=7.14, p=0.012]. Sleep‐onset latency reduced in the intervention group at follow‐up, with a marginally significant effect [F(1,28)=3.52, p=0.071]. The Internet‐based self‐help program improves subjective sleep quality and sleep‐onset latency among adult workers.

Phrenic nerve injury after radiofrequency ablation of lung tumors: retrospective evaluation of the incidence and risk factors.

PURPOSE To retrospectively investigate the incidence of and risk factors for phrenic nerve injury after radiofrequency (RF) ablation of lung tumors. MATERIALS AND METHODS The study included 814 RF ablation procedures of lung tumors. To evaluate the development of phrenic nerve injury, chest radiographs obtained before and after the procedure were examined. Phrenic nerve injury was assumed to have developed if the diaphragmatic level was elevated after the procedure. To identify risk factors for phrenic nerve injury, multiple variables were compared between cases of phrenic nerve injury and randomly selected controls by using univariate analyses. Multivariate analysis was then performed to identify independent risk factors. RESULTS Evaluation of phrenic nerve injury from chest radiographs was possible after 786 procedures. Evidence of phrenic nerve injury developed after 10 cases (1.3%). Univariate analysis revealed that larger tumor size (≥ 20 mm; P = .014), proximity of the phrenic nerve to the tumor (< 10 mm; P < .001), the use of larger electrodes (array diameter or noninsulated tip length ≥ 3 cm; P = .001), and higher maximum power applied during ablation (≥ 100 W; P < .001) were significantly associated with the development of phrenic nerve injury. Multivariate analysis demonstrated that the proximity of the phrenic nerve to the tumor (< 10 mm; P < .001) was a significant independent risk factor. CONCLUSIONS The incidence of phrenic nerve injury after RF ablation was 1.3%. The proximity of the phrenic nerve to the tumor was an independent risk factor for phrenic nerve injury.

Maternal working hours and early childhood overweight in Japan: a population-based study.

Maternal Working Hours and Early Childhood Overweight in Japan: A Population‐based Study: Toshiharu MITSUHASHI, et al. Department of Epidemiology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences—

Radiofrequency Ablation of Lung Tumors Using a Multitined Expandable Electrode: Impact of the Electrode Array Diameter on Local Tumor Progression

PURPOSE To retrospectively investigate the impact of the electrode array diameter on local tumor progression after lung radiofrequency ablation. MATERIALS AND METHODS This study included 651 lung tumors treated using multitined expandable electrodes and followed for ≥ 6 months. The mean long-axis tumor diameter was 12 mm ± 7 (range, 2-42 mm). The difference between electrode array diameter and tumor diameter (DAT) was used to investigate the impact of the electrode array diameter. All tumors were classified into 2 groups according to various variables including DAT (≥ 10 mm or < 10 mm). The primary technique efficacy rates were calculated using Kaplan-Meier analysis and compared between the 2 groups of each variable using the log-rank test. In addition, crude and multivariate multilevel survival analyses were performed by sequentially including DAT and the other variables in 5 models. RESULTS The median DAT for 651 tumors was 12 mm (range, -15 to 24 mm). The technique efficacy rate was significantly lower in the < 10 mm DAT group than in the ≥ 10 mm group (P < .001). In the crude and multivariate multilevel survival analyses, < 10 mm DAT was a significant risk factor for local progression in all models except model 5 (P = .067). In the ≥ 10 mm group, the technique efficacy rates were not significantly different between the 2 ≥ 10 mm DAT subgroups (10 to <15 mm DAT vs ≥ 15 mm DAT). CONCLUSIONS DAT is an important risk factor for local progression. We recommend an electrode that is ≥ 10 mm larger than the tumor diameter.

A counterfactual approach to bias and effect modification in terms of response types

BackgroundThe counterfactual approach provides a clear and coherent framework to think about a variety of important concepts related to causation. Meanwhile, directed acyclic graphs have been used as causal diagrams in epidemiologic research to visually summarize hypothetical relations among variables of interest, providing a clear understanding of underlying causal structures of bias and effect modification. In this study, the authors aim to further clarify the concepts of bias (confounding bias and selection bias) and effect modification in the counterfactual framework.MethodsThe authors show how theoretical data frequencies can be described by using unobservable response types both in observational studies and in randomized controlled trials. By using the descriptions of data frequencies, the authors show epidemiologic measures in terms of response types, demonstrating significant distinctions between association measures and effect measures. These descriptions also demonstrate sufficient conditions to estimate effect measures in observational studies. To illustrate the ideas, the authors show how directed acyclic graphs can be extended by integrating response types and observed variables.ResultsThis study shows a hitherto unrecognized sufficient condition to estimate effect measures in observational studies by adjusting for confounding bias. The present findings would provide a further understanding of the assumption of conditional exchangeability, clarifying the link between the assumptions for making causal inferences in observational studies and the counterfactual approach. The extension of directed acyclic graphs using response types maintains the integrity of the original directed acyclic graphs, which allows one to understand the underlying causal structure discussed in this study.ConclusionsThe present findings highlight that analytic adjustment for confounders in observational studies has consequences quite different from those of physical control in randomized controlled trials. In particular, the present findings would be of great use when demonstrating the inherent distinctions between observational studies and randomized controlled trials.

Robotically Driven CT-guided Needle Insertion: Preliminary Results in Phantom and Animal Experiments

Purpose To evaluate the accuracy of the remote-controlled robotic computed tomography (CT)-guided needle insertion in phantom and animal experiments. Materials and Methods In a phantom experiment, 18 robotic and manual insertions each were performed with 19-gauge needles by using CT fluoroscopic guidance for the evaluation of the equivalence of accuracy of insertion between the two groups with a 1.0-mm margin. Needle insertion time, CT fluoroscopy time, and radiation exposure were compared by using the Student t test. The animal experiments were approved by the institutional animal care and use committee. In the animal experiment, five robotic insertions each were attempted toward targets in the liver, kidneys, lungs, and hip muscle of three swine by using 19-gauge or 17-gauge needles and by using conventional CT guidance. The feasibility, safety, and accuracy of robotic insertion were evaluated. Results The mean accuracies of robotic and manual insertion in phantoms were 1.6 and 1.4 mm, respectively. The 95% confidence interval of the mean difference was -0.3 to 0.6 mm. There were no significant differences in needle insertion time, CT fluoroscopy time, or radiation exposure to the phantom between the two methods. Effective dose to the physician during robotic insertion was always 0 μSv, while that during manual insertion was 5.7 μSv on average (P < .001). Robotic insertion was feasible in the animals, with an overall mean accuracy of 3.2 mm and three minor procedure-related complications. Conclusion Robotic insertion exhibited equivalent accuracy as manual insertion in phantoms, without radiation exposure to the physician. It was also found to be accurate in an in vivo procedure in animals.

A typology of four notions of confounding in epidemiology

Confounding is a major concern in epidemiology. Despite its significance, the different notions of confounding have not been fully appreciated in the literature, leading to confusion of causal concepts in epidemiology. In this article, we aim to highlight the importance of differentiating between the subtly different notions of confounding from the perspective of counterfactual reasoning. By using a simple example, we illustrate the significance of considering the distribution of response types to distinguish causation from association, highlighting that confounding depends not only on the population chosen as the target of inference, but also on the notions of confounding in distribution and confounding in measure. This point has been relatively underappreciated, partly because some literature on the concept of confounding has only used the exposed and unexposed groups as the target populations, while it would be helpful to use the total population as the target population. Moreover, to clarify a further distinction between confounding “in expectation” and “realized” confounding, we illustrate the usefulness of examining the distribution of exposure status in the target population. To grasp the explicit distinction between confounding in expectation and realized confounding, we need to understand the mechanism that generates exposure events, not the product of that mechanism. Finally, we graphically illustrate this point, highlighting the usefulness of directed acyclic graphs in examining the presence of confounding in distribution, in the notion of confounding in expectation.

Individual risk alleles of susceptibility to schizophrenia are associated with poor clinical and social outcomes

Many patients with schizophrenia have poor clinical and social outcomes. Some risk alleles closely related to the onset of schizophrenia have been reported to be associated with their clinical phenotypes, but the direct relationship between genetic vulnerability to schizophrenia and clinical/social outcomes of schizophrenia, as evaluated by both practical clinical scales and ‘real-world’ function, has not been investigated. We evaluated the clinical and social outcomes of 455 Japanese patients with schizophrenia by severity of illness according to the Clinical Global Impression-Severity Scale (CGI-S) and social outcomes by social adjustment/maladjustment at 5 years after the first visit. We examined whether 46 single nucleotide polymorphisms (SNPs) selected from a Japanese genome-wide association study of susceptibility to schizophrenia were associated with clinical and social outcomes. We also investigated the polygenic risk scores of 46 SNPs. Allele-wise association analysis detected three SNPs, including rs2623659 in the CUB and Sushi multiple domains-1 (CSMD1) gene, associated with severity of illness at end point. The severity of illness at end point was associated with treatment response, but not with the severity of illness at baseline. Three SNPs, including rs2294424 in the C6orf105 gene, were associated with social outcomes. Point estimates of odds ratios showed positive relationships between polygenic risk scores and clinical/social outcomes; however, the results were not statistically significant. Because these results are exploratory, we need to replicate them with a larger sample in a future study.

Alternative definitions of "proportion eliminated"

308 | www.epidem.com

Radiofrequency ablation of pulmonary tumors near the diaphragm

PURPOSE To retrospectively evaluate the feasibility, safety, and efficacy of radiofrequency ablation (RFA) of lung tumors located near the diaphragm. MATERIALS AND METHODS A total of 26 patients (15 men, 11 women; mean age, 61.5 years±13.0 [SD]) with a total of 29 lung tumors near the diaphragm (i.e., distance<10mm) were included. Mean tumor diameter was 11.0mm±5.3 (SD) (range, 2-23mm). Efficacy of RFA, number of adverse events and number of adverse events with a grade≥3, based on the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0, were compared between patients with lung tumors near the diaphragm and a control group of patients with more distally located lung tumors (i.e., distance≥10mm). RESULTS RFA was technically feasible for all tumors near the diaphragm. Four grade 3 adverse events (1 pneumothorax requiring pleurodesis and 3 phrenic nerve injuries) were observed. No grade≥4 adverse events were reported. The median follow-up period for tumors near the diaphragm was 18.3 months. Local progression was observed 3.3 months after RFA in 1 tumor. The technique efficacy rates were 96.2% at 1 year and 96.2% at 2 years and were not different, from those observed in control subjects (186 tumors; P=0.839). Shoulder pain (P<0.001) and grade 1 pleural effusion (P<0.001) were more frequently observed in patients with lung tumor near the diaphragm. The rates of grade≥3 adverse events did not significantly differ between tumors near the diaphragm (4/26 sessions) and the controls (7/133 sessions) (P=0.083). CONCLUSION RFA is a feasible and effective therapeutic option for lung tumors located near the diaphragm. However, it conveys a higher rate of shoulder pain and asymptomatic pleural effusion by comparison with more distant lung tumors.