Hope modified the association between distress and incidence of self-perceived medical errors among practicing physicians: prospective cohort study.

The presence of hope has been found to influence an individual's ability to cope with stressful situations. The objective of this study is to evaluate the relationship between medical errors, hope and burnout among practicing physicians using validated metrics. Prospective cohort study was conducted among hospital based physicians practicing in Japan (N = 836). Measures included the validated Burnout Scale, self-assessment of medical errors and Herth Hope Index (HHI). The main outcome measure was the frequency of self-perceived medical errors, and Poisson regression analysis was used to evaluate the association between hope and medical error. A total of 361 errors were reported in 836 physician-years. We observed a significant association between hope and self-report of medical errors. Compared with the lowest tertile category of HHI, incidence rate ratios (IRRs) of self-perceived medical errors of physicians in the highest category were 0.44 (95%CI, 0.34 to 0.58) and 0.54 (95%CI, 0.42 to 0.70) respectively, for the 2(nd) and 3(rd) tertile. In stratified analysis by hope score, among physicians with a low hope score, those who experienced higher burnout reported higher incidence of errors; physicians with high hope scores did not report high incidences of errors, even if they experienced high burnout. Self-perceived medical errors showed a strong association with physicians' hope, and hope modified the association between physicians' burnout and self-perceived medical errors

Quality of life assessment and reporting in randomized controlled trials: a study of literature published from Japan

BACKGROUND: Standardization of quality of life (QOL) assessment and reporting in clinical trials is an imperative issue. While English-speaking countries have led this movement in standardization, there persists to be a limited amount of information from non-English-speaking including Japan. In this study, we bibliographically analyze the reporting of randomized controlled trials (RCT) conducted in Japan that used a QOL instrument. METHODS: A PubMed search of reports published between 1970–2003 followed by an examination of QOL reporting and its frequency of use in RCTs published from Japan. RESULTS: Percentages of QOL reporting in RCTs have increased between 1970–2003 both worldwide (0% for 1970–1974 to 4.4% for 2000–2003) and in Japan (0% to 1.8% for the identical periods). We found and evaluated 46 RCT reports published from Japan (32 in English, 14 in Japanese). The most commonly studied clinical condition was cancer (26, 56.5%) and the most common intervention was drug therapy (29, 63.0%). QOL was used as the primary endpoint in 10 studies (21.7%). Authors used established QOL instruments in 12 studies (26.1%), developed original instruments in 8 studies (17.5%) and assessed the symptoms or performance status in 10 studies (21.7%). Authors conceptually defined QOL in only 6 studies (13.0%). Neither response rate nor number of respondents for questionnaire surveys was specified in 16 studies (34.8%); furthermore, 11 studies (23.9%) did not describe respondents' attributes. CONCLUSIONS: Findings on relative frequency suggested that Japanese authors of RCT reports have less interest in QOL instruments than other international researchers in Western Europe and North America. Examination of RCT reports published from Japan revealed that there were several points to be improved in reporting QOL instruments. This study highlights the need to define QOL measures specific to clinical specialty and to examine methodology for assessing and reporting QOL

Estimating a preference-based index from the Japanese SF-36

Objective: The main objective of the study was to estimate a preference-bascd Short Form (SF)-6D index from the SF-36 for Japan and compare it with the UK results. Study Design and Setting: The SF-6D was translated into Japanese. Two hundred and forty-nine health states defined by this version of the SF-6D were then valued by a representative sample of 600 members of the Japanese general population using standard gamble (SG). These health-state values were modeled using classical parametric random-effect methods with individual-level data and ordinary least squares (OLS) on mean health-state values, together with a new nonparametric approach using Bayesian methods of estimation. Results: All parametric models estimated on Japanese data were found to perform less well than their UK counterparts in terms of poorer goodness of fit, more inconsistencies, larger prediction errors and bias, and evidence of systematic bias in the predictions. Nonparametric models produce a substantial improvement in out-of-sample predictions. The physical, role, and social dimensions have relatively larger decrements than pain and mental health compared with those in the United Kingdom. Conclusion: The differences between Japanese and UK valuations of the SF-6D make it important to use the Japanese valuation data set estimated using the nonparametric Bayesian technique presented in this article. (C) 2009 Elsevier Inc. All rights reserved

Impact of Vonoprazan Triple-Drug Blister Packs on H. pylori Eradication Rates in Japan: Interrupted Time Series Analysis

INTRODUCTION: Helicobacter pylori eradication therapy requires a complex prescribing schedule combining clarithromycin, amoxicillin, and a proton-pump inhibitor (PPI) or potassium-competitive acid blocker (P-CAB, vonoprazan). To reduce the burden of complex prescribing and increase adherence, a vonoprazan triple-drug blister pack comprising all three medications was launched in June 2016. This study aimed to assess the impact of the combination blister pack on eradication success rate in Japan immediately after launch. METHODS: We performed an interrupted time series analysis using a large administrative claims database of 7, 300, 000 insured individuals. We identified 36, 570 patients who received first-line clarithromycin triple therapy from June 2015 to May 2016 (prelaunch) and 35, 721 who received the same therapy from July 2016 to June 2017 (post-launch). The primary outcome was the success rate of clarithromycin triple therapy and the secondary outcomes were proportion of vonoprazan use and proportion of combination blister pack use. RESULTS: The success rate of clarithromycin triple therapy increased by 2.44% (95% confidence interval [CI] 1.36-3.52; P < 0.0001) after the launch of the vonoprazan triple-drug blister pack. The proportion of vonoprazan use and proportion of combination blister pack use increased by 12.7% (95% CI 10.0-15.3; P < 0.0001) and 29.2% (95% CI 25.4-32.9; P < 0.0001), respectively. CONCLUSIONS: Launch of the vonoprazan triple-drug blister pack had a significant impact on the success rate of clarithromycin triple therapy, with greater proportions of vonoprazan and combination blister pack use. Introducing an easy-to-use formulation may be effective in changing prescribing practice and subsequent patient outcomes

Longitudinal association between mental health and future antibiotic prescriptions in healthy adults: Results from the LOHAS

Objectives: To investigate the association of mental health and subjective physical functioning with future antibiotic prescriptions. Design: Prospective cohort study. Setting: A rural town in Japan. Participants: Participants who completed the baseline survey (2008-2010) of the Locomotive Syndrome and Health Outcomes in the Aizu Cohort Study (LOHAS) were recruited. Participants were limited to those without comorbidities according to the Charlson comorbidity index. Participants using antibiotics at baseline were excluded. Mental health and physical functioning were assessed using the Mental Health and Physical Functioning domains of the Short-Form 12 Health Survey, and depressive symptoms were assessed using the Mental Health Inventories at baseline. Main outcome measures: The main outcome was antibiotic prescriptions found in claims data during 1 year after the baseline survey. Results: A total of 967 participants were included in the analysis, and 151 (15.6%) participants with at least one missing variable for the confounding factors were excluded, leaving 816 participants for the primary analysis. Among the 816 participants, 65 (8.0%) were newly prescribed at least one antibiotic during the 1-year follow-up period. The most frequently prescribed antibiotics were third-generation cephalosporins (44 prescriptions; 35.5%), macrolides (28 prescriptions; 22.6%), and quinolones (23 prescriptions; 18.6%). A multivariable logistic regression analysis showed an association between higher mental health scores and future antibiotic prescriptions (adjusted odds ratio [AOR], 1.40 per 1 standard deviation [SD] increase; 95% confidence interval [CI], 1.03-1.90), whereas no significant relationship was observed between Physical Functioning scores and future antibiotic prescriptions (AOR, 0.95 per 1 SD increase; 95% CI, 0.75-1.22). During the secondary analysis, adults with depressive symptoms were less likely to be prescribed antibiotics (AOR, 0.27; 95% CI, 0.11-0.70). Conclusions: Better mental health was associated with increased future antibiotic prescriptions for healthy community-dwelling Japanese adults, suggesting that mentally healthier adults could be a target population for reducing antimicrobial use

Attitudes of the Japanese public and doctors towards use of archived information and samples without informed consent: Preliminary findings based on focus group interviews

BACKGROUND: The purpose of this study is to explore laypersons' attitudes toward the use of archived (existing) materials such as medical records and biological samples and to compare them with the attitudes of physicians who are involved in medical research. METHODS: Three focus group interviews were conducted, in which seven Japanese male members of the general public, seven female members of the general public and seven physicians participated. RESULTS: It was revealed that the lay public expressed diverse attitudes towards the use of archived information and samples without informed consent. Protecting a subject's privacy, maintaining confidentiality, and communicating the outcomes of studies to research subjects were regarded as essential preconditions if researchers were to have access to archived information and samples used for research without the specific informed consent of the subjects who provided the material. Although participating physicians thought that some kind of prior permission from subjects was desirable, they pointed out the difficulties involved in obtaining individual informed consent in each case. CONCLUSIONS: The present preliminary study indicates that the lay public and medical professionals may have different attitudes towards the use of archived information and samples without specific informed consent. This hypothesis, however, is derived from our focus groups interviews, and requires validation through research using a larger sample

The role of digital rectal examination for diagnosis of acute appendicitis: A systematic review and meta-analysis

Background: Digital rectal examination (DRE) has been traditionally recommendedto evaluate acute appendicitis, although several reports indicate its lack of utility for this diagnosis. No metaanalysis has examined DRE for diagnosis of acute appendicitis. Objectives: To assess the role of DRE for diagnosis of acute appendicitis. Data Sources: Cochrane Library, PubMed, and SCOPUS from the earliest available date of indexing through November 23, 2014, with no language restrictions. Study Selection: Clinical studies assessing DRE as an index test for diagnosis of acute appendicitis. Data Extraction and Synthesis: Two independent reviewers extracted study data and assessed the quality, using the Quality Assessment of Diagnostic Accuracy Studies 2 tool. Bivariate random-effects models were used for the pooled sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, and diagnostic odds ratio (DOR) as point estimates with 95% confidence intervals (CI). Main Outcomes and Measures: The main outcome measure was the diagnostic performance of DRE for diagnosis of acute appendicitis. Results: We identified 19 studies with a total of 7511 patients. The pooled sensitivity and specificity were 0.49 (95% CI 0.42-0.56) and 0.61 (95% CI 0.53-0.67), respectively. The positive and negative likelihood ratios were 1.24 (95% CI 0.97-1.58) and 0.85 (95% CI 0.70-1.02), respectively. The DOR was 1.46 (0.95-2.26). Conclusion and Relevance: Acute appendicitis cannot be ruled in or out through the result of DRE. Reconsideration is needed for the traditional teaching that rectal examination should be performed routinely in all patients with suspected appendicitis

Changes in Drug Utilization After Publication of Clinical Trials and Drug-Related Scandals in Japan: An Interrupted Time Series Analysis, 2005–2017

Background: Breaches of ethics undermine the practice of medicine. In Japan, two major scandals involving clinical research and drug marketing occurred after the publication of clinical trials. To study the effects of those scandals, we evaluated changes in the use of first-generation angiotensin II receptor blockers (ARBs) after publication of relevant clinical trials and also after the subsequent scandals. Methods: We conducted a quasi-experimental design of an interrupted time series analysis (ITSA) on nationwide monthly drug-market data covering 12 years (2005 to 2017) in Japan. The main outcome was the use of first-generation ARBs (valsartan, candesartan, and losartan). The two exposures were the publication of ARB-related clinical-trial results (October 2006) and subsequent ARB-related scandals involving research and marketing (February 2013). A generalized estimating equation model was fitted for ITSA with a log link, Poisson distribution, robust variance estimators, and seasonality adjustment. Results: The publication of clinical trials was associated with 12% increase in the use of first-generation ARBs in Japan, and the subsequent ARB-related scandals was associated with 19% decrease. The decrease in the use of first-generation ARBs after the scandals was greater than the increase in their use after the publication of clinical-trial results. The net effect of the two exposures was a 9% decrease in the use of first-generation ARBs. Conclusions: The scandals were associated with decrease in the use of first-generation ARBs, and that decrease was greater than the increase associated with the publication of “successful” clinical trials, making the net effect not zero but negative

Incidence of gastrointestinal perforation associated with bevacizumab in combination with neoadjuvant chemotherapy as first-line treatment of advanced ovarian, fallopian tube, or peritoneal cancer: analysis of a Japanese healthcare claims database

[Objective] To assess the incidence of bevacizumab-associated gastrointestinal (GI) perforation during first-line treatment of patients with ovarian, fallopian tube, or peritoneal cancer receiving neoadjuvant chemotherapy (NAC) in Japanese real-world clinical practice. [Methods] A retrospective study was conducted using a healthcare claims database owned by Medical Data Vision Co., Ltd. (study period, 2008–2020). Patients who initiated first-line treatment of ovarian, fallopian tube, or peritoneal cancer were identified and divided into NAC and primary debulking surgery (PDS) groups. The incidence of bevacizumab-associated GI perforation was compared within the NAC group and between the groups. [Results] Paclitaxel + carboplatin (TC) was most commonly used as first-line treatment (39.5% and 59.6% in the NAC and PDS groups, respectively). TC + bevacizumab was used in 9.3% and 11.6% of patients in the NAC and PDS groups, respectively. In the NAC group receiving TC, the proportion of patients with risk factors for GI perforation was lower among patients with versus without concomitant bevacizumab. The incidence of GI perforation in the NAC group was 0.38% (1/266 patients) in patients receiving TC + bevacizumab and 0.18% (2/1, 131 patients) in patients receiving TC without bevacizumab (risk ratio=2.13; 95% confidence interval [CI]=0.19 to 23.36; risk difference=0.20; 95% CI=−0.58 to 0.97). None of the 319 patients in the PDS group receiving TC + bevacizumab had GI perforation. [Conclusion] No notable increase was observed in GI perforation associated with NAC containing bevacizumab. We conclude that bevacizumab is prescribed with sufficient care in Japan to avoid GI perforation

Association of kyphotic posture with loss of independence and mortality in a community-based prospective cohort study: the Locomotive Syndrome and Health Outcomes in Aizu Cohort Study (LOHAS)

[Objectives] This study aimed to investigate the association between kyphotic posture and future loss of independence (LOI) and mortality in community-dwelling older adults. [Design] Prospective cohort study. [Setting] Two Japanese municipalities. [Participants] We enrolled 2193 independent community-dwelling older adults aged≥65 years at the time of their baseline health check-up in 2008. Kyphotic posture was evaluated using the wall-occiput test (WOT) and classified into three categories: non-kyphotic, mild (>0 and ≤4 cm) and severe (>4 cm). [Primary and secondary outcome measures] The primary outcome was mortality and the secondary outcomes were LOI (new long-term care insurance certification levels 1–5) and a composite of LOI and mortality. A Cox proportional hazards model was used to estimate the adjusted HRs (aHRs). [Results] Of the 2193 subjects enrolled, 1621 were included in the primary analysis. Among these, 272 (17%) and 202 (12%) were diagnosed with mild and severe kyphotic postures, respectively. The median follow-up time was 5.8 years. Compared with the non-kyphotic group, the aHRs for mortality were 1.17 (95% CI 0.70 to 1.96) and 1.99 (95% CI 1.20 to 3.30) in the mild and severe kyphotic posture groups, respectively. In the secondary analysis, a consistent association was observed for LOI (mild: aHR 1.70, 95% CI 1.13 to 2.55; severe: aHR 2.08, 95% CI 1.39 to 3.10) and the LOI-mortality composite (mild: aHR 1.27, 95% CI 0.90 to 1.79; severe: aHR 1.83, 95% CI 1.31 to 2.56). [Conclusion] Kyphotic posture was associated with LOI and mortality in community-dwelling older adults. Identifying the population with kyphotic posture using the WOT might help improve community health