Experiences of using clinical pathways in hospitals: Perspectives of quality improvement personnel.

AIM: This study aimed to explore the experiences of quality improvement personnel in implementing clinical pathways (CPs) in Korean hospitals. DESIGN: A qualitative study using focus-group interviews was conducted with healthcare professionals in charge of CP development and management in hospitals. METHODS: Sixteen quality improvement personnel from eight tertiary and seven general hospitals were recruited using purposive sampling. The verbatim transcribed data were analysed using qualitative content analysis. RESULTS: Three key themes emerged: (1) the primary focus of CP development on surgeries through concerted efforts between management and frontline healthcare professionals; (2) CP fidelity management using indicators and feedback to relevant staff or departments; and (3) positive outcomes, despite concerns about system safety. The factors affecting CP use included availability of clinical evidence, flexibility of CPs, top management and clinical leadership, physicians' perceptions of CPs, computerized support systems, and external policies and regulations.

Adherence to follow-up examination after positive fecal occult blood test results affects colorectal cancer mortality: A Korea population-based cohort study.

BACKGROUND: The impact of adherence to follow-up examination after a fecal occult blood test (FOBT) remains ill-defined. AIM: To evaluate the impact of adherence to the follow-up examination on clinical outcomes in individuals with positive FOBT results. METHODS: This was a retrospective cohort study involving Korean individuals aged 50 years or older who participated in the National Cancer Screening Program for CRC from 2009 to 2010. Individuals who underwent a confirmative examination within a year after positive FOBT results were included in compliant group, and those who did not were included in non-compliant group. The incidence and stage of CRC, and 5-year survival were compared between two groups. RESULTS: 5,914 were diagnosed with CRC in the compliant group and 2,973 in the non-compliant group. The proportion of advanced-stage CRC was significantly higher in the non-compliant group (localized CRC 44.6% vs. 36.7% and distant CRC 8.7% vs. 12.5%, p< 0.0001). The survival probability within 5 years was 71.0% in the non-compliant group and 85.9% in the compliant group (hazard ratio 1.70, 95% CI, 1.52-1.90, p< 0.001). CONCLUSION: Individuals who underwent follow-up examination 1 year or more after positive FOBT had a lower survival rate compared with that in those who underwent examination within 1 year.

Increased risk of death with codeine use in the elderly over 85 years old and patients with respiratory disease: A case-control study using retrospective insurance claims database.

To investigate the risk of mortality associated with exposure to codeine, considering various risk groups, using population-based national insurance claims data.National sample cohort data from the National Health Insurance Service of South Korea (2002-2013) was used in this case-control study. Cases were defined as patients with a death record between January 1, 2002 and December 31, 2013. Each case was matched to 10 controls based on age, sex, baseline comorbidities, and year of death. Definition of exposure was codeine prescription in 30 days prior to death and sensitivity analyses were performed for 15 and 60-day exposures. Adjusted odds ratios (aORs) with 95% confidence intervals (CIs) were estimated using conditional logistic regression adjusting for benzodiazepine, other opioids, anesthetics, hypnotics, CYP2D6 inducer, CYP3A4 inducer, and the Charlson comorbidity index.A total of 19,341 cases and 185,700 matched controls were included. The overall risk associated with codeine use and mortality risk was not significant (aOR 1.08, 95% CI 1.00-1.16). Sensitivity analyses with different exposure time window also presented similar insignificant results. However, in the subgroup analyses, codeine use was associated with an increased risk of mortality in the >85-year-old age group (aOR 2.38, 95% CI 1.26-4.48) and patients with respiratory disease (aOR 1.29, 95% CI 1.17-1.42).Although no statistically significant association was found in codeine exposure and mortality risk between cases and controls, we demonstrated that the elderly over 85 years old and patients with respiratory disease are associated with a higher risk with codeine exposure. Therefore, a more cautious practice of codeine prescription in these groups might be needed.

Assisted Breathing with a Diaphragm Pacing System: A Systematic Review.

PURPOSE: Patients with respiratory failure associated with neurological dysfunction often require mechanical ventilator support, which poses increased economic burden and ventilator-associated complications. A diaphragm pacing system (DPS) is an implanted device that provides respiratory support for such patients. In this systematic review, we reviewed the literature to assess the safety and efficacy of DPS for patients with respiratory failure resulting from amyotrophic lateral sclerosis (ALS) or cervical spinal cord injuries. MATERIALS AND METHODS: The following databases were searched from July 10 to July 30, 2018: MEDLINE, EMBASE, Cochran library, KoreaMed, Research Information Sharing Service, Korean studies Information Service System, Korea Institute of Science and Technology Information, and Korean Medical database. The abstracts and full texts of the searched articles were reviewed by two reviewers. RESULTS: The search keywords generated 197 articles: two randomized controlled trials, two case-control studies, and one case report involving patients with ALS; one cohort study, one case-control study, and two case reports involving patients with cervical spine injury; and one case report involving patients with both conditions were included. The primary outcome was safety profile (complications and adverse event) and efficacy (overall survival and sleep improvement). Complications and adverse events were more common in patients with ALS and spinal cord injury receiving DPS than in controls. Efficacy outcomes were inconsistent across ALS studies. CONCLUSION: Based on safety and efficacy results, we do not support using DPS to manage respiratory failure in patients with ALS or cervical spine injury.

The Impact of National Surveillance for Liver Cancer: Results from Real-World Setting in Korea.

Background/Aims: The National Liver Cancer Surveillance Program (NLCSP) was established in 2003 to reduce the socioeconomic burden imposed by liver cancer (LC). We aimed to investigate the effectiveness of the NLCSP in South Korea with respect to survival benefits and cost, after adjusting for various confounding factors. Methods: We used the National Health Insurance Service claims data linked with the NLCSP from 2004 to 2015. The Cox proportional hazard model and generalized linear model were used to determine the effects of the NLCSP on the early detection of LC, survival, and medical costs. Results: From 2006 to 2010, 66,632 patients (surveillance group: 10,527 and no surveillance group: 56,105) newly diagnosed with LC were included in the study. The odds of the early detection of LC was 1.82 (95% confidence interval [CI], 1.73 to 1.93) times higher among patients who participated in the NLCSP once within the 2-year period prior to the diagnosis of LC than among those who did not participate in the surveillance program. The mortality rate of patients who participated in the NLCSP was 22.0% lower (hazard ratio, 0.78; 95% CI, 0.76 to 0.80) than that of those who did not participate. When compared with the group who did not participate in surveillance, the group who participated in the NLCSP had higher total medical costs; however, their cost per day was lower after adjustment during the follow-up period. Conclusions: This study highlights the survival benefit in patients who participated in the NLCSP and the need for continuous improvements of the NLCSP in South Korea.

Clinical Factors Associated with Adherence to the Follow-Up Examination after Positive Fecal Occult Blood Test in National Colorectal Cancer Screening.

Background: The compliance with the follow-up examination after a positive fecal occult blood test (FOBT) is lower than expected. We aimed to evaluate the adherence rate to the follow-up examination in patients with a positive FOBT and to identify the clinical factors associated with this adherence. METHODS: The study population comprised adults aged ≥50 years who participated in the National Cancer Screening Program for colorectal cancer (CRC) in 2013. Compliance was defined as undergoing follow-up examination within 1 year of a positive FOBT. RESULTS: From 214,131 individuals with a positive FOBT, 120,911 (56.5%) were in the compliance group and 93,220 (43.5%) were in the non-compliance group. On multivariate analysis, good compliance was associated with men (odds ratio (OR) = 1.12, 95% confidence interval (CI) (1.09-1.15)), younger ages (70-79 years, OR = 2.19 (2.09-2.31); 60-69 years, OR = 3.29 (3.13-3.46); 50-59 years, OR = 3.57 (3.39-3.75) vs. >80 years), previous experience of CRC screening (a negative FOBT, OR = 1.18 (1.15-1.21); a positive FOBT, OR = 2.42 (2.31-2.54)), absent previous experience of colonoscopy or barium enema (OR = 2.06 (1.99-2.13)), higher economic income (quartile, 75%, OR = 1.14 (1.11-1.17); 100%, OR = 1.22 (1.19-1.25)), current smokers (OR = 1.12 (1.09-1.15)), alcohol intake (OR = 1.03 (1.01-1.05)), active physical activity (≥3 times/week, OR = 1.13 (1.11-1.15)), depression (OR = 1.11 (1.08-1.14)), and present comorbidities (Charlson Comorbidity Index, ≥1). CONCLUSION: This study identified clinical factors, namely, male, younger ages, prior experience of fecal test, absent history of colonoscopy or double-contrast barium enema (DCBE) within 5 years, and high socioeconomic status to be associated with good adherence to the follow-up examination after a positive FOBT.

All-Cause Mortality Associated with Tramadol Use: A Case-Crossover Study.

INTRODUCTION: Although the mortality risk associated with tramadol use in children has triggered the revision of tramadol drug labeling, the mortality risk in adults has not been thoroughly explored. OBJECTIVE: The objective of this study was to evaluate whether tramadol use is associated with mortality in various risk groups. METHODS: This was a case-crossover study addressing the period of 2004-2013, using data from the National Sample Cohort (National Health Insurance Service, South Korea). Patients who were prescribed tramadol at least once prior to their death were included. A 30-day hazard (case) period (with a 10-day washout period) was adopted and matched to three control periods. Logistic regression was used to estimate adjusted odds ratios (aORs) and their 95% confidence intervals (CIs). Adjustments were made for time-variant factors (co-medications, surgeries, and acute respiratory conditions). RESULTS: A total of 19,443 individuals were identified, with a small number of young individuals (n = 33, 0.2%). Tramadol use was associated with an increased mortality risk (aOR 1.77, 95% CI 1.67-1.87). Advanced age (> 75 years) (aOR 2.61, 95% CI 2.28-2.99) and renal (aOR 2.90, 95% CI 1.67-1.87) and hepatic (aOR 2.09, 95% CI 1.62-2.68) diseases were associated with the highest risks. CONCLUSION: Overall, there was an increased mortality risk associated with tramadol in the adult population. However, as residual confounding cannot be completely removed in large observational studies, this must be carefully interpreted in the decision-making regarding patient care.

Risk factors for developing liver cancer in people with and without liver disease.

BACKGROUND: The National Liver Cancer Surveillance Program (NLCSP) targets patients with liver diseases that lead to liver cancer in South Korea. This study aimed to investigate the risk of liver disease leading to liver cancer using nationally representative data to establish an efficient NLCSP. METHODS: This study used data from the National Health Insurance Service National Sample Cohort (NHIS-NSC) from 2002 to 2013. A retrospective matched cohort design was applied to compare the development of liver cancer in patients with and without liver disease. Cox- proportional hazard regression for liver cancer with competing risk of death was performed for all subjects or each group stratified according to age or income level. RESULTS: A total of 66,192 patients with liver disease and matched subjects without liver disease were included in the study. The incidences of liver cancer among patients with and without liver disease within a median 8-year follow-up period were 2.68% (n = 1,772) and 0.34% (n = 210), respectively. Cox- regression analysis for liver cancer incidence indicated that cirrhosis had the highest risk (hazard ratio [HR]: 18.13, 95% confidence interval [CI]: 15.24-21.58), followed by hepatitis B (HR: 9.32, 95% CI: 8.00-10.85). Subgroup analysis showed that the presence of liver disease was an important risk factor in younger as well as elderly people, and a higher risk of liver disease was also observed in the patients with Medicaid. CONCLUSIONS: Attention should be paid to the development of liver cancer in young people under 50 years old and preventive efforts to decrease the incidence of liver cancer among Medicaid recipients is needed.

Comparative Efficacy and Safety of Long-acting Injectable and Oral Second-generation Antipsychotics for the Treatment of Schizophrenia: A Systematic Review and Meta-analysis.

We aimed to compare the efficacy and safety of long-acting injectable (LAI) and oral second-generation antipsychotics (SGAs) in treating schizophrenia by performing a systematic review and meta-analysis. MEDLINE, EMBASE, PsycINFO, CINAHL, and the Cochrane Library, as well as five Korean databases, were systemically searched to identify studies published from 2000 to 16 April 2015, which compared the efficacy and safety of LAI and oral SGAs. Using data from randomized controlled trials (RCTs), meta-analyses were conducted. In addition, the GRADE (the Grading of Recommendations, Assessment, Development and Evaluation) approach was applied to explicitly assess the quality of the evidence. A total of 30 studies including 17 RCTs and 13 observational studies were selected. The group treated with LAI SGAs was characterized by significantly lower relapse rates, longer times to relapse and fewer hospital days, but also by a higher occurrence of extrapyramidal syndrome and prolactin-related symptoms than that in the group treated with oral SGAs. Our findings demonstrate that there is moderate to high level of evidence suggesting that in the treatment of schizophrenia, LAI SGAs have higher efficacy and are associated with higher rates of extrapyramidal syndrome and prolactin-related symptoms. Additionally, the use of LAI SGAs should be combined with appropriate measures to reduce dopamine D2 antagonism-related symptoms.

Comparative efficacy of biological agents in methotrexate-refractory rheumatoid arthritis patients: a Bayesian mixed treatment comparison.

BACKGROUND/AIMS: Biological agents (biologics) targeting proinflammatory signaling have emerged as an important treatment option in rheumatoid arthritis (RA). Despite the clinical effectiveness of biologics for patients with RA who do not respond to 'traditional' disease-modifying anti-rheumatic drugs (DMARDs), there are concerns regarding their cost and long-term safety. In this study, we aimed to compare the efficacy of various biologics and traditional DMARDs in RA patients refractory to methotrexate (MTX). METHODS: Four DMARDs (hydroxychloroquine, sulfasalazine, MTX, lef lunomide) and five anti-tumor necrosis factor drugs (adalimumab, etanercept, golimumab, inf liximab, and certolizumab) were selected. A systematic search of published studies was performed from inception through July 2013. Randomized trials of adults with MTX-refractory RA comparing two or more of the selected medications were included. Among 7,938 titles identified, in total, 16 head-to-head trials were selected. Two reviewers independently abstracted the study data and assessed methodological quality using the Cochrane Risk of Bias. Comparative efficacy was analyzed using a Bayesian mixed treatment comparison (MTC). RESULTS: In total, 9, 4, and 11 studies were included for the outcome measures of the Health Assessment Questionnaire (HAQ), Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) < 2.6 (remission), and American College of Rheumatology (ACR) 70 response, respectively. The treatments with the highest efficacy for each outcome measure were certolizumab combined with MTX, golimumab combined with MTX, and certolizumab combined with MTX, respectively. CONCLUSIONS: Based on MTC analysis, using data from published randomized controlled trials, certolizumab and golimumab combined with MTX showed the highest efficacy in the three outcome measures (HAQ, DAS28-ESR < 2.6, and ACR 70 response) in MTX-refractory RA patients.

Association between metformin use and mortality in patients with type 2 diabetes mellitus and localized resectable pancreatic cancer: a nationwide population-based study in korea.

BACKGROUND: Preclinical studies support an antitumor effect of metformin. However, clinical studies have conflicting results and metformin's effect remains controversial. The aim of this study was to evaluate metformin's effect on clinical outcomes in diabetic patients with pancreatic cancer treated with curative resection. RESULTS: A total of 764 patients underwent curative resection, met none of the exclusion criteria, and were prescribed oral hypoglycemic agents. The cancer-specific survival (5-year, 31.9% vs. 22.2%, p < 0.001) was significantly higher in the 530 metformin users than in the 234 diabetic metformin non-users. After multivariable adjustments, metformin users had significantly lower cancer-specific mortality as compared with metformin non-users (hazard ratio, 0.727; 95% confidence interval, 0.611-0.868). Cubic spline regression analysis demonstrated significantly decreased cancer-specific mortality with increasing dose of metformin (p = 0.0047). MATERIALS AND METHODS: Data were provided from the Korea Central Cancer Registry and the National Health Insurance Service in the Republic of Korea. The study cohort consisted of 28,862 patients newly diagnosed with pancreatic cancer between 2005 and 2011. Metformin exposure was determined from prescription information from 6 months before the first diagnosis of pancreatic cancer to last follow-up. The main outcome was cancer-specific survival. CONCLUSIONS: This large study indicates that metformin might decrease cancer-specific mortality rates in localized resectable pancreatic cancer patients with pre-existing diabetes, independently of other factors, with a dose-response relationship.

Association of Metformin Use With Cancer-Specific Mortality in Hepatocellular Carcinoma After Curative Resection: A Nationwide Population-Based Study.

Many preclinical reports and retrospective population studies have shown an anticancer effect of metformin in patients with several types of cancer and comorbid type 2 diabetes mellitus (T2DM). In this work, the anticancer effect of metformin was assessed in hepatocellular carcinoma (HCC) patients with T2DM who underwent curative resection.A population-based retrospective cohort design was used. Data were obtained from the National Health Insurance Service and Korea Center Cancer Registry in the Republic of Korea, identifying 5494 patients with newly diagnosed HCC who underwent curative resection between 2005 and 2011. Crude and adjusted hazard ratios (HRs) were calculated using Cox proportional hazard models to estimate effects. In the sensitivity analysis, we excluded patients who started metformin or other oral hypoglycemic agents (OHAs) after HCC diagnosis to control for immortal time bias.From the patient cohort, 751 diabetic patients who were prescribed an OHA were analyzed for HCC-specific mortality and retreatment upon recurrence, comparing 533 patients treated with metformin to 218 patients treated without metformin. In the fully adjusted analyses, metformin users showed a significantly lower risk of HCC-specific mortality (HR 0.38, 95% confidence interval [CI] 0.30-0.49) and retreatment events (HR 0.41, 95% CI 0.33-0.52) compared with metformin nonusers. Risks for HCC-specific mortality were consistently lower among metformin-using groups, excluding patients who started metformin or OHAs after diagnosis.In this large population-based cohort of patients with comorbid HCC and T2DM, treated with curative hepatic resection, metformin use was associated with improvement of HCC-specific mortality and reduced occurrence of retreatment events.