Sun-Young Jung

The significance of the trial outcome was associated with publication rate and time to publication

OBJECTIVESnThis study aims to comprehensively assess the publication of clinical trial results and factors associated with their publication.nnnSTUDY DESIGN AND SETTINGnPhase II and III trials of advanced breast cancer registered on ClinicalTrials.gov between October 1, 2000, and September 30, 2012, were identified. Publications were searched by using PubMed and reviewing those listed on the registry site. The main outcomes were publication rate, public availability of results, and time to publication.nnnRESULTSnOf 352 phase II and 74 phase III trials, 12.5% and 31.1% were published, whereas 46.9% and 58.1% had publicly available results, respectively. Compared to those with significant results, studies with nonsignificant results had delays in time to publication (Pxa0<xa00.001). Even after adjusting for funding source and phase type, the significance of study outcomes was a significant factor that affected time to publication (hazard ratioxa0=xa06.02; 95% confidence interval: 3.59, 10.07; Pxa0<xa00.001), with trials with significant outcomes taking less time to publish than those with nonsignificant outcomes.nnnCONCLUSIONnUnderreporting of results and nonpublication or delays in the publication of negative results were identified in registered trials of advanced breast cancer. Thus, further initiatives appear necessary to urgently address such publication bias.

Combined primary tumor and extracranial metastasis status as constituent factor of prognostic indices for predicting the overall survival in patients with brain metastases.

We retrospectively analyzed the prognostic factors on overall survival (OS) in patients with brain metastasis (BM) and evaluated the role of combined primary tumor and extracranial metastasis (ECM) status as a constituent factor for prognostic index. This study involved 897 patients with BMs who underwent radiotherapy between April 2003 and December 2009. Among the clinical parameters, multivariate analysis showed that age, Karnofsky performance status (KPS), combined primary tumor and ECM status, number of BMs, and treatment group were significant prognostic factors for OS (P < 0.05). To compare the discriminatory ability of 5 prognostic indices, i.e., recursive partitioning analysis (RPA), basic score for BMs (BSBM), score index for radiosurgery (SIR), graded prognostic assessment (GPA), and modified GPA including the combined primary tumor and ECM status (mGPA), the Akaike information criteria (AIC) were calculated. The mGPA showed the lowest AIC value, followed by RPA, GPA, SIR, and BSBM, in that order. It is implicated that modified score of pre-existing factors (i.e., age and KPS) and addition of the combined primary tumor and ECM status to the prognostic index can improve its discriminatory ability and the combined primary tumor and ECM status may be useful as one of constituent factors for prognostic index.

Treatment patterns of knee osteoarthritis patients in Korea

Background/Aims To evaluate the treatment patterns of knee osteoarthritis (OA) patients in South Korea. Methods Using the Korean nationwide claims database, all knee OA patients in Korea during 2014 were identified by the knee OA diagnostic code (M17) or any OA diagnostic code (M15 to M19) in combination with a procedure for a knee X-ray. Patterns of medications such as nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids (CSs), analgesics, and symptomatic slow acting drugs for OA (SYSADOA) were analyzed. Prevalence and characteristics of knee OA patients who received a CS intra-articular injection (IAI) were also evaluated. Results We identified 2,016,516 knee OA patients whose age (mean ± standard deviation) was 63.2 ± 10.8 years. The number of patients with at least one use of NSAIDs, analgesics, CS, and SYSADOA were 82.5%, 32.2%, 8.6%, and 43.4%, respectively. The use of herbal SYSADOAs was 29.7%. For regular users (medication possession ratios ≥ 50%), the use of NSAIDs was substantially decreased (48.8%), while the use of SYSADOA (37.3%) and CS (6.7%) were not significantly changed. The number of CS IAI users among knee OA patients was 0.18%; they were slightly older (64.4 ± 10.9 vs. 63.2 ± 10.8, p < 0.01) and more skewed towards females (75.7% vs. 71.5%, p < 0.01) than patients who had not received CS IAI. Conclusions In Korea, the use of SYSADOA or CS in knee OA patients was relatively high. Further studies on the effectiveness and the safety of these treatment options for knee OA are needed.

Drug holiday patterns and bisphosphonate-related osteonecrosis of the jaw

OBJECTIVESnThere is limited evidence regarding the appropriate length of a bisphosphonate (BP) holiday to reduce the risk of osteonecrosis of the jaw (ONJ). In this cross-sectional study, we investigated the population-based patterns of the gaps between BP discontinuation and ONJ diagnosis.nnnSUBJECTS AND METHODSnWe used the claims database of the National Health Insurance Service in Korea. Among BP users between 2006 and 2015, incident ONJ cases during 2010-2015 with no history of ONJ in the last 4xa0years were identified. We assessed the time gap from the last BP administration to ONJ diagnosis.nnnRESULTSnAmong 1,569 incident ONJ cases, 836 (53.3%) occurred after BP discontinuation. The cumulative proportions of ONJ occurrence within 1xa0month, 3xa0months, 1xa0year, 2xa0years, and 3xa0years after discontinuation were 58.9%, 70.8%, 87.0%, 93.2%, and 96.1%, respectively. The length of drug holidays showed no significant difference between patients with or without comorbid cancer and diabetes mellitus (p-value, 0.12 and 0.52, respectively). However, the use of injectable BP formulations significantly affected ONJ incidence (pxa0<xa00.01).nnnCONCLUSIONSnMost ONJ cases occurred within 3xa0years from BP suspension, with a higher prevalence among BP injection users with 1xa0year or lesser BP holiday.

Comparative effectiveness of oral pharmacologic interventions for knee osteoarthritis: A network meta-analysis

Abstract Objectives: To explore the relative efficacy of oral pharmacologic interventions in the treatment of knee OA. Methods: A systematic literature review was conducted using the MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials databases to identify trials conducted in patients with knee OA with a minimum 6 weeks of follow-up. The standardized mean differences of the change from baseline to week 6 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain between the treatment groups were estimated using Bayesian random-effects network meta-analyses. Subgroup analyses of baseline pain status (high, pain score ≥60u2009mm; low, pain score <60u2009mm) were performed. Results: Of 4067 manuscripts, 44 were included in the evidence synthesis. Etoricoxib had the highest ranking for improving WOMAC pain (probability of being top ranked, p (best)u2009=u2009.43) followed by naproxen (p (best)u2009=u2009.12), acetaminophen (AAP) (p (best)u2009=u2009.04), and celecoxib (p (best)u2009=u2009.02). The top three ranked interventions were etoricoxib, celecoxib and aceclofenac in the higher pain group, and tramadol, celecoxib, and diclofenac in the lower pain group. Conclusion: In the overall analysis, etoricoxib, celecoxib, and aceclofenac had the highest rankings for improving WOMAC pain. The ability to improve knee OA symptoms may differ depending on baseline pain and radiologic features.

Comprehensive behavioral analyses of anoctamin1/TMEM16A-conditional knockout mice

Aims: Anoctamin‐1 (TMEM16A) is a calcium‐activated chloride channel that is involved in numerous physiological conditions. Its role has been identified in electrophysiological and histological studies of genetic knockout animals. Recent cellular localization studies have shown that anoctamin‐1 is co‐expressed with presynaptic proteins, therefore its role in presynaptic terminals has been suggested. However, behavioral studies are lacking because conventional knockouts of anoctamin‐1 are lethal after birth. In this study, we explored the role of anoctamin‐1 in presynaptic terminals by analyzing the behavior of mice with conditional knockouts of anoctamin‐1 in synapsin1‐expressing cells. Main methods: Using a synapsin1‐Cre system, we selectively ablated anoctamin‐1 in synapsin1 expressing cells. The mice were used in the behavioral experiments when they were between 6 and 9months of age. Key findings: The mice with the conditional knockout of anoctamin‐1 in synapsin1‐expressing cells displayed impaired social behavior. In addition, the mice showed depressive‐like behavior and decreased weight. However, these animals displayed normal locomotor activity, cognitive function, and motor coordination. Significance: These results suggested that anoctamin‐1 is involved in psychiatric behavior because of its role in the regulation of synaptic transmission in presynaptic terminals.

Impact of Osteoarthritis on Household Catastrophic Health Expenditures in Korea

Background Osteoarthritis (OA) is a disease of old age whose prevalence is increasing. This study explored the impact of OA on household catastrophic health expenditure (CHE) in Korea. Methods We used data on 5,200 households from the Korea Health Panel Survey in 2013 and estimated annual living expenses and out-of-pocket (OOP) payments. Household CHE was defined when a households total OOP health payments exceeded 10%, 20%, 30%, or 40% of the households capacity to pay. To compare the OOP payments of households with OA individuals and those without OA, OA households were matched 1:1 with households containing a member with other chronic disease such as neoplasm, hypertension, heart disease, cerebrovascular disease, diabetes, or osteoporosis. The impact of OA on CHE was determined by multivariable logistic analysis. Results A total of 1,289 households were included, and households with and without OA patients paid mean annual OOP payments of

Steroid phobia among general users of topical steroids: a cross-sectional nationwide survey

2,789 and

Prescription of Zolpidem and the Risk of Fatal Motor Vehicle Collisions: A Population-Based, Case-Crossover Study from South Korea

2,607, respectively. The prevalence of household CHE at thresholds of 10%, 20%, 30%, and 40% were higher in households with OA patients than in those without OA patients (P < 0.001). The presence of OA patients in each household contributed significantly to CHE at thresholds of 10% (odds ratio [OR], 1.48; 95% confidence interval [CI], 1.16–1.87), 20% (OR, 1.29; 95% CI, 1.01–1.66), and 30% (OR, 1.37; 95% CI, 1.05–1.78), but not of 40% (OR, 1.17; 95% CI, 0.87–1.57). Conclusion The presence of OA patients in Korean households is significantly related to CHE. Policy makers should try to reduce OOP payments in households with OA patients.

Parametric study on design of composite-foam-resin concrete sandwich structures for precision machine tool structures

Abstract Objective: The aim of this study was to assess steroid phobia among general users of topical corticosteroids and to analyze factors associated with steroid phobia. Methods: A cross-sectional nationwide survey was conducted using an online panel with participants stratified by age, sex, and region. Those aged 18–65u2009years with experience of topical steroid use within the past 1u2009year were included. Results: Of the 3000 respondents included, 929 (31%) had steroid phobia. Among those with steroid phobia, 322 (35%) reported that their fear developed after obtaining information from the media. Weight gain, asthma, skin thinning, growth stunting, and skin aging were the side effects cited as the main reasons behind development of steroid phobia. Female respondents and those with experience of the side effects of topical steroids were more likely to have steroid phobia, while those who obtained information on topical steroid use from a healthcare professional were less likely to have steroid phobia. Conclusions: Steroid phobia among general users of topical steroids appears to be relatively high despite most of them being non-chronic topical steroid users. Healthcare professionals should not refrain from counseling patients, but instead actively address the issues leading to fears in patients.