Surgery is so far the most effective treatment for early-stage non-small cell lung cancer (NSCLC). Since the 1990s, the pathology spectrum of early-stage lung cancer has gradually changed because of the increased detection of ground-glass opacity (GGO). The findings from preoperative thin-section computed tomography are strong predictors for the invasiveness and lymph node involvement of GGO, and limited surgery is believed to be implemented safely for radiological less invasive lesions, which calls into question the dominance of lobectomy. After the JCOG0201 trial establishing the radiologic criteria of pathological noninvasiveness for lung adenocarcinoma, the Japan Clinical Oncology Group (JCOG) and the West Japan Oncology Group (WJOG) have successively carried out a series of prospective imaging-guided trials to investigate the optimal surgical procedure for early-stage lung cancer. JCOG0804, was a single-arm, non-randomized, confirmatory trial to evaluate the efficacy and safety of sublobar resection (wedge resection and segmentectomy) for GGO dominant peripheral lung cancer. The primary end point was 5-year relapse-free survival. JCOG0802/WJOG4607L, was a multicentre, open-label, phase 3, randomized, controlled, non-inferiority trial to investigate if segmentectomy was non-inferior to lobectomy in patients with small-sized peripheral NSCLC. The primary endpoint was 5-year overall survival. JCOG1211 was also a non-randomized confirmatory trial to confirm the efficacy of a segmentectomy for clinical T1N0 lung cancer with dominant GGO. The primary endpoint was 5-year relapse-free survival. The findings of JCOG0804 and JCOG0802, and the primary analysis results of JCOG1211 have been officially published. This article systematically reviewed and interpreted the results of the JCOG lung cancer surgery trial series.
Carcinoma, Non-Small-Cell Lung/surgery* ; Clinical Trials as Topic ; Clinical Trials, Phase III as Topic ; Humans ; Japan ; Lung Neoplasms/surgery* ; Multicenter Studies as Topic ; Prospective Studies ; Randomized Controlled Trials as Topic

Controlled Clinical Trials as Topic ; Humans ; Randomized Controlled Trials as Topic

Real world study (RWS) has attracted more and more attention of neonatologists since it involves less clinical intervention and is closer to actual clinical conditions. Generally speaking, RWS means to select treatment measures based on the internal efficacy and safety verified by randomized controlled trials (RCTs), more representative samples, and patients' actual conditions and their guardians' will and conduct follow-up evaluation of short- and long-term outcomes, in order to further evaluate the external efficacy and safety of interventional measures. Most guidelines for clinical practice are based on RCTs and lack the support of real world data. Strengthening of neonatal RWS helps to make these guidelines more practical and thus promotes the development of neonatal medicine.
Humans ; Infant, Newborn ; Neonatology ; Noninvasive Ventilation ; Practice Guidelines as Topic ; Pragmatic Clinical Trials as Topic ; Randomized Controlled Trials as Topic ; methods

BACKGROUND/AIMS: The aim of this study was to assess the efficacy and safety of tofacitinib (5 and 10 mg twice daily) in patients with active rheumatoid arthritis (RA). METHODS: A systematic review of randomized controlled trials (RCTs) that examined the efficacy and safety of tofacitinib in patients with active RA was performed using the Medline, Embase, and Cochrane Controlled Trials Register databases as well as manual searches. RESULTS: Five RCTs, including three phase-II and two phase-III trials involving 1,590 patients, met the inclusion criteria. The three phase-II RCTs included 452 patients with RA (144 patients randomized to 5 mg of tofacitinib twice daily, 156 patients randomized to 10 mg of tofacitinib twice daily, and 152 patients randomized to placebo) who were included in this meta-analysis. The American College of Rheumatology 20% response rate was significantly higher in the tofacitinib 5- and 10-mg groups than in the control group (relative risk [RR], 2.445; 95% confidence interval [CI], 1.229 to 4.861; p = 0.011; and RR, 2.597; 95% CI, 1.514 to 4.455; p = 0.001, respectively). The safety outcomes did not differ between the tofacitinib 5- and 10-mg groups and placebo groups with the exception of infection in the tofacitinib 10-mg group (RR, 2.133; 95% CI, 1.268 to 3.590; p = 0.004). The results of two phase-III trials (1,123 patients) confirmed the findings in the phase-II studies. CONCLUSIONS: Tofacitinib at dosages of 5 and 10 mg twice daily was found to be effective in patients with active RA that inadequately responded to methotrexate or disease-modifying antirheumatic drugs, and showed a manageable safety profile.
Antirheumatic Agents/administration & dosage/adverse effects/*therapeutic use ; Arthritis, Rheumatoid/*drug therapy ; Clinical Trials, Phase II as Topic ; Clinical Trials, Phase III as Topic ; Humans ; Janus Kinases/antagonists & inhibitors ; Methotrexate/therapeutic use ; Piperidines/administration & dosage/adverse effects/*therapeutic use ; Protein Kinase Inhibitors/administration & dosage/adverse effects/therapeutic use ; Pyrimidines/administration & dosage/adverse effects/*therapeutic use ; Pyrroles/administration & dosage/adverse effects/*therapeutic use ; Randomized Controlled Trials as Topic ; Treatment Outcome

PURPOSE: Optimal methods for communication skills training (CST) are an active research area, but the effects of CST on communication performance in objective structured clinical examinations (OSCEs) has not been closely studied. Student roleplay (RP) for CST is common, although volunteer simulated patient (SP) CST is cost-effective and provides authentic interactions. We assessed whether our volunteer SP CST program improved OSCE performance compared to our previous RP strategy. METHODS: We performed a retrospective, quasi-experimental study of 2 second-year medical student cohorts' OSCE data in Australia. The 2014 cohort received RP-only CST (N=182) while the 2016 cohort received SP-only CST (N=148). The t-test and analysis of variance were used to compare the total scores in 3 assessment domains: generic communication, clinical communication, and physical examination/procedural skills. RESULTS: The baseline characteristics of groups (scores on the Australian Tertiary Admission Rank, Undergraduate Medicine and Health Sciences Admission Test, and medicine program interviews) showed no significant differences between groups. For each domain, the SP-only CST group demonstrated superior OSCE outcomes, and the difference between cohorts was significant (P<0.01). The superiority of volunteer SP CST over student RP CST in terms of OSCE performance outcomes was found for generic communication, clinical communication, and physical examination/procedural skills. CONCLUSION: The better performance of the SP cohort in physical examination/procedural skills might be explained by the requirement for patient compliance and cooperation, facilitated by good generic communication skills. We recommend a volunteer SP program as an effective and efficient way to improve CST among junior medical students.
Australia ; Clinical Competence ; Cohort Studies ; Humans ; Non-Randomized Controlled Trials as Topic ; Patient Compliance ; Patient Simulation ; Retrospective Studies ; Students, Medical ; Volunteers

OBJECTIVES: This study aimed to identify and systematically review the literature on the use of mobile technology in nursing education. The research findings could evidence the effectiveness of mobile technology in undergraduate nursing students' learning outcomes. METHODS: Computerized searches were conducted using the Ovid-MEDLINE, Ovid-EMBASE, Cochrane Library, and CINAHL databases for relevant primary studies and limited to those between 2000 and February 2018. Only randomized controlled trials (RCTs) and quasi-experimental studies published in either English or Korean were included and critically appraised using Joanna Briggs Institute tools. RESULTS: Seven RCTs and 7 quasi-experimental studies were identified. The mobile device and intervention applied varied throughout all the studies. Studies published earlier in the 2000s found that immediate access to clinical and pharmacological referencing information through the mobile device increased students' efficacy in clinical practice. Later studies, which were mostly conducted in Korea, reported that smartphone-based applications could promote nursing students' learning motivation and satisfaction but not their clinical skills and knowledge. CONCLUSIONS: We still seem to be in the beginning stage of implementing mobile technology in nursing education due to the limited implication of mobile technology and inconsistent research conclusions. In the future, rigorous primary empirical studies are needed to suggest the effective use of mobile devices in nursing education.
Clinical Competence ; Education ; Education, Nursing* ; Korea ; Learning ; Mobile Applications ; Motivation ; Non-Randomized Controlled Trials as Topic ; Nursing* ; Smartphone

PURPOSE: This study evaluated the effect of a teaching model to improve cultural competency (TMCC) for Korean undergraduate nursing students. METHODS: A nonequivalent control group pretest/posttest quasi-experimental study was conducted with a convenience sample of 168 undergraduate nursing students in South Korea. The experimental group of 121 seniors was taught a 13-week teaching model in order to improve cultural competence. A control group with 47 junior students underwent nursing major courses, but did not take this teaching model. Before and after the program, students' level of cultural competency was measured using the Questionnaire for Cultural Competence (QCC) consisting of three sub-scales: “awareness and desire,” “encounter,” and “nursing skill and knowledge.” RESULTS: After the experiment, the experimental group showed significantly higher improvement in the Questionnaire for Cultural Competence in the three sub-scales of “awareness and desire,” “encounter,” and “nursing skill and knowledge” than the control group (p= < .050). CONCLUSION: A teaching model to improve cultural competence was effective in improving Korean undergraduate nursing students' cultural competency. Further studies need to be repeated in order to identify the effectiveness of the teaching model to improve cultural competency with graduate or clinical nurses.
Clinical Competence ; Cultural Competency ; Cultural Diversity ; Education, Nursing ; Humans ; Korea ; Non-Randomized Controlled Trials as Topic ; Nursing ; Students, Nursing

The STandards for Reporting Interventions in Clinical Trials Of Moxibustion (STRICTOM), in the form of a checklist and descriptions of checklist items, were designed to improve reporting of moxibustion trials, and thereby facilitating their interpretation and replication. The STRICTOM checklist included 7 items and 16 sub-items. These set out reporting guidelines for the moxibustion rationale, details of moxibustion, treatment regimen, other components of treatment, treatment provider background, control and comparator interventions, and precaution measures. In addition, there were descriptions of each item and examples of good reporting. It is intended that the STRICTOM can be used in conjunction with the main CONSORT Statement, extensions for nonpharmacologic treatment and pragmatic trials, and thereby raise the quality of reporting of clinical trials of moxibustion. Further comments will be solicited from the experts of the CONSORT Group, the STRICTA Group, acupuncture and moxibustion societies, and clinical trial authors for optimizing the STRICTOM.
Clinical Trials as Topic ; methods ; standards ; Humans ; Moxibustion ; methods ; standards ; Randomized Controlled Trials as Topic ; Research Design ; standards

Based on detailed explanation of the herbal CONSORT statement, and the consideration of the character of traditional Chinese drugs, to discuss the standardization of reporting traditional Chinese drug trials. The standards of reporting traditional Chinese drug trials are not consolidated yet. In the year 2006, Reporting Randomized, Controlled Trials of Herbal Interventions: An Elaborated CONSORT Statement was developed by the CONSORT group and published. This herbal CONSORT statement includes 5 parts, and totally 22 items, in which the items of participant criteria, intervention, control setting and outcomes, et al. are elaborated to be adaptable to herbal intervention trials. This herbal CONSORT statement has provided valuable basis for the development of standards of reporting traditional Chinese drug trials, though it is not completely adaptive to be the reporting standards in consideration of the background theory and the animal drugs and mineral drugs that traditional Chinese drugs contain. The proper reporting standards of traditional Chinese drug trials should take the different types of drugs and the different purposes of trials into consideration. The trial reports of drugs that must be applied under the instruction of traditional Chinese medicine (TCM) theory should report participant criteria that include TCM syndrome differentiation and other important characters of TCM interventions.
Clinical Trials as Topic ; standards ; Medicine, Chinese Traditional ; standards ; Publishing ; standards ; Randomized Controlled Trials as Topic ; standards

Non-randomized studies (NRS) have gradually attracted people's attention in the field of clinical medicine. In this paper, the importance of NRS was emphasized on the viewpoints of the coherence of scientific research, the limitation of randomized control trials (RCTs), the immanent characteristics of TCM clinical practice and the actual requirement of complex intervention in clinical practice. And two main points in evaluation and implementation of NRS differed to those in RCTs were put forward, i.e. the first, the full-scale design of the study with the professional characteristics should be described very explicitly, especially the speciality of the objects, intervention elements and indexes for effectiveness evaluation, etc.; the second, the control of bias and evaluation of effectiveness, and their influence on conclusion induction should be fully taken into consideration. At the same time, the key step in improving the quality of NRS of TCM and integrative medicine was preliminary discussed in this paper.
Clinical Trials as Topic ; Humans ; Medicine, Chinese Traditional ; Randomized Controlled Trials as Topic ; Research Design