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

PURPOSE: This study aims to examine the effects of nursing interventions based on the Extended Theory of Planned Behavior (ETPB) regarding self-efficacy for exercise (SEE), physical activity (PA), physical function (PF), and quality of life (QOL) in patients with lung cancer who have undergone pulmonary resection.METHODS: This quasi-experimental study was conducted between July 2015 and June 2018 in two university-affiliated hospitals. The intervention included pre-operative patient education, goal setting (action and coping planning), and feedback (behavior intention and perceived behavioral control). The intervention group (IG) (n=51) received nursing interventions from the day before surgery to 12 months after lung resection, while the comparison group (CG) (n=36) received usual care. SEE, PA, PF (dyspnea, functional status, and 6-minute walking distance [6MWD]), and QOL were measured before surgery and at one, three, six, and 12 months after surgery. Data were analyzed using the χ² test, Fisher's exact test, Mann–Whitney U test, t-test, and generalized estimation equations (GEE).RESULTS: There were significant differences between the two groups regarding SEE (χ²=13.53, p=.009), PA (χ²=9.51, p=.049), functional status (χ²=10.55, p=.032), and 6MWD (χ²=15.62, p=.004). Although there were no time or group effects, the QOL mental component (Z=−2.78, p=.005) of the IG was higher than that of the CG one month after surgery. Interventions did not affect dyspnea or the QOL physical component.CONCLUSION: The intervention of this study was effective in improving SEE, PA, functional status, and 6MWD of lung cancer patients after lung resection. Further extended investigations that utilize ETPB are warranted to confirm these results.
Dyspnea ; Exercise ; Humans ; Intention ; Lung Neoplasms ; Lung ; Motor Activity ; Non-Randomized Controlled Trials as Topic ; Nursing ; Patient Education as Topic ; Quality of Life ; Self Efficacy ; Walking

To systematically evaluate the adverse drug reaction(ADR) of Tripterygium Glycosides Tablets(TGT) in the treatment of rheumatoid arthritis(RA). Four Chinese databases(CNKI, VIP, WanFang, SinoMed) and three English databases(Cochrane Library, EMbase, PubMed), from the time of database establishing to August 2019, were systematically retrieved to collect literature on the treatment of all types of RA with TG. Screening literature and extracting data according to inclusion and exclusion criteria. All studies were assessed by using internationally recognized methodological quality assessment tools or reporting quality evaluation criteria, with data being extracted and Meta-analyzed. There were 79 studies included, randomized controlled trials(RCT) containing TGT in the treatment group, non-randomized controlled trials(non-RCT), case series, case reports, and RCT containing TGT only in the control group were covered. There were in the control group; 765 ADR of 2 214 patients in 30 RCT(treatment group given TGT), 11 non-RCT and 7 case reports. The results of Meta-analysis of these 48 literatures showed that the overall incidence of ADRs was 0.23(95%CI[0.22,0.24]); ADR mainly occured in the reproductive, gastrointestinal, skin and accessories, blood, hepatobiliary system damage and the incidence of ADR in systems mentioned about respectively were 0.14(95%CI[0.12,0.17]),0.07(95%CI[0.06,0.08]),0.06(95%CI[0.04,0.07]),0.04(95%CI[0.03,0.05]),0.04(95%CI[0.03,0.05]). Further subgroup analysis results showed that the incidence of total ADR, especially the gastrointestinal, reproductive and cutaneous ADR of patients with treatment alone was higher than that in those paients with MTX or MTX+LEF therapy; The incidence of ADR, especially the gastrointestinal ADR, was also positively correlated with daily dose and course of treatment, while the incidence of different systems ADR was also correlated with different drug manufacturers, for instance, damage on the female reproductive system occurs most frequently in Hunan manufacture TGT administration, same as the damage on skin and accessories induced by TGT from Jiangsu manufacture. Above all, The clinical treatment of TGT for RA will cause multi-system ADR, with the highest incidence in the reproductive system, followed by the gastrointestinal system, which is closely related to the way of medication(monotherapy), daily dose, course of medication and drug manufacturer. Therefore, it is recommended that, in the treatment of RA, using TGT in combination, low dose or short-course medication, take measures to protect the reproductive system, stomach and liver, and paying attention to the drug manufacturer as well response of patients during administration should be valued to avoid ADRs to the maximum possibility.
Arthritis, Rheumatoid/drug therapy* ; Drugs, Chinese Herbal/therapeutic use* ; Glycosides/therapeutic use* ; Humans ; Non-Randomized Controlled Trials as Topic ; Randomized Controlled Trials as Topic ; Tablets ; Tripterygium/chemistry*

BACKGROUND: To objectively investigate accommodative response to various refractive stimuli in subjects with normal accommodation. METHODS: This prospective, non-randomized clinical trial included 64 eyes of 32 subjects with a mean spherical equivalent −1.4 diopters (D). We evaluated changes in accommodative power, pupil diameter, astigmatic value, and axis when visual stimuli were applied to binocular, monocular (dominant eye, non-dominant eye, ipsilateral, and contralateral), and pinhole conditions. Visual stimuli were given at 0.25 D (4 m), 2 D (50 cm), 3 D (33 cm), and 4 D (25 cm) and accommodative response was evaluated using open view binocular autorefractor/keratometer. RESULTS: The accommodative response to binocular stimulus was 90.9% of the actual refractive stimulus, while that of the monocular stimulus was 84.6%. The binocular stimulus induced a smaller pupil diameter than did the monocular stimulus. There was no difference in accommodative response between the dominant eye and non-dominant eye or between ipsilateral and contralateral stimuli. As the refractive stimuli became stronger, the absolute astigmatic value increased and the direction of the astigmatism axis became more horizontal. Pinhole glasses required 10%–15% less accommodative power compared with the monocular condition. CONCLUSION: Binocular stimuli enable more precise and effective accommodation than do monocular stimuli. Accommodative response is composed of 90% true accommodation and 10% pseudo-accommodation, and the refractive stimulus in one eye affects the contralateral eye to the same extent. This should be taken into account when developing guidelines for wearing smart glasses while driving, as visual stimulation is applied to only one eye, but far distance attention is constantly needed. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03557346
Astigmatism ; Eyeglasses ; Glass ; Non-Randomized Controlled Trials as Topic ; Photic Stimulation ; Prospective Studies ; Pupil ; Telescopes*

PURPOSE: Caring for patients with dementia is a challenging issue entailing heavy responsibility. Many interventions for caregivers have been developed, but their effectiveness is not clear. This study aimed to examine how, why, and under what circumstances interventions for dementia caregivers affected their burden of caring. METHODS: Authors used a realist review approach to explore the evidence for how different interventions reduce the burden of dementia caregivers. We completed the literature review about the burden of dementia caregivers and extracted the theoretical concepts to explain context-mechanism-outcome configuration why an intervention may be effective in some situations and not others. Six databases were searched for experimental or quasi-experimental studies conducted from 2008 to 2017. Of 1,225 screened studies, 10 studies were eligible for inclusion. RESULTS: None of the studies included all the derived contexts while explaining in detail the mechanism of the intervention effectiveness. Among contexts, the variable of other family members requiring care was not included in all studies. Among the analyzed studies, no studies have applied repeated intervention. Most studies included only some variables of context and mechanism, and these variables did not directly explain the effectiveness of intervention. The effect of outcome variables was significant for each study, and the effects of research intervention and national services could not be separately described. CONCLUSION: Authors conclude that Korean culture's emphasis on relationships with others increases the burden of care. In context, Confucian norms and traditional femininity of Korea were reflected in the core. It is necessary to check the homogeneity of participants and the design of intervention to verify the effectiveness of the outcome variable of psychological burden.
Caregivers ; Dementia ; Femininity ; Humans ; Korea ; Non-Randomized Controlled Trials as Topic

PURPOSE: To determine whether Lactobacillus reuteri DSM 17938 plays a role in absorption of iron preparations given to children with iron deficiency anemia (IDA). METHODS: We performed a quasi-experimental study involving pre- and postintervention tests using a control group in North Sulawesi province, Indonesia, between July and September 2017. We conducted a single-blind controlled trial that included primary school children who were diagnosed with IDA based on reticulocyte hemoglobin equivalent (Ret-He) levels <27.8 pg/L. RESULTS: A total of 66 children were randomized into 2 groups. Thirty-four children received iron preparations with the addition of L. reuteri DSM 17938 (group 1), whereas the other 32 received iron preparations alone (group 2). The baseline Ret-He levels before intervention were similar in both groups. After 14 days of intervention, mean Ret-He level in group 1 changed from 24.43±1.64 to 28.21±1.72 pg/L (P=0.000). Mean Ret-He level in group 2 changed from 24.31±1.42 to 27.03±2.14 pg/L (P=0.000). Statistical analysis showed a significant increase in Ret-He levels in both groups; Ret-He levels were significantly higher in the experimental group than in the control group (P<0.05). CONCLUSION: Children with IDA receiving iron preparations with L. reuteri DSM 17938 for 14 days show higher Ret-He levels than those receiving iron preparations alone.
Absorption ; Anemia ; Anemia, Iron-Deficiency ; Child ; Humans ; Indonesia ; Iron ; Lactobacillus reuteri ; Lactobacillus ; Non-Randomized Controlled Trials as Topic ; Reticulocytes

Psychological distress is common in lung cancer patients with a poor prognosis. The present study aims to investigate the efficacy of collaborative care for patients with newly diagnosed inoperable lung cancer in South Korea. The study is a three-arm parallel-groups non-randomized clinical trial with an active arm that includes distressed patients who receive collaborative care, one comparison arm that includes distressed patients who receive enhanced usual care, and another comparison arm that includes non-distressed patients. In total, 267 consecutive patients newly diagnosed with medically inoperative lung cancer will be recruited. The primary outcomes are the changes in Hospital Anxiety and Depression Scale-depression and the Distress Thermometer at 12 and 32 weeks after enrollment. Sub-analyses of patients in the active arm of the study will include a comparison of the efficacy of a combination of oral antidepressant (escitalopram) treatment and collaborative care versus that of collaborative care alone.
Anxiety ; Arm ; Depression ; Humans ; Korea ; Lung Neoplasms ; Lung ; Non-Randomized Controlled Trials as Topic ; Prognosis ; Thermometers

To explore the medication rules of herbal prescriptions for nonalcoholic fatty liver disease,and analyze the possible drug targets and interactions,in order to explore the mechanisms of the herbs. Randomized controlled trials of herbal prescriptions for treating nonalcoholic fatty liver disease were collected from CNKI,Wan Fang,VIP,Sino Med and PubMed databases. The properties,flavors and meridian tropism of herbs were analyzed by using systematic cluster analysis method with SPSS 19. 0 software. Subsequently,the association rules of herbs were analyzed by using Clementine 12. 0 software. Finally,the interactions between targets and relevant signaling pathways were analyzed by Traditional Chinese Medicine Systems Pharmacology Database(TCMSP),Search Tool for the Retrieval of Interacting Genes/Proteins(STRING) and Kyoto Encyclopedia of Genes and Genomes(KEGG). In the 88 prescriptions screened out,the commonly used herbs were Salvia miltiorrhiza,Bupleurum chinense,Alisma orientale,and Crataegus pinnatifida,and the potential signaling pathways were PPAR signaling pathway and calcium signaling pathway. The results showed that the main effects of herbal prescriptions were to improve blood flow/clear blood stasis,clear heatiness/dampness,promote digestion and strengthen spleen. And its mechanism of action may be achieved through the regulation of PPAR signaling pathway and calcium signaling pathway.
Data Mining ; Drugs, Chinese Herbal ; therapeutic use ; Humans ; Medicine, Chinese Traditional ; Meridians ; Non-alcoholic Fatty Liver Disease ; drug therapy ; Randomized Controlled Trials as Topic ; Signal Transduction

PURPOSE: To determine the effects of a child and parent program on developing social skills for preventing violent behaviors in children aged 60~72 months through a specially developed pre and posttest, control group, quasi-experimental study.METHODS: A social skills development program based on Gardner's Multiple Intelligence Theory was used. The data were collected using the Social Skills Assessment Scale (SSAS), a Chart to Monitor Verbal and Behavioral Violence in Children, the Parental Attitude Scale and the Parent Interview Form. This quasi-experimental study that included a pretest, posttest, and control group had a sample comprising 67 children and parents, with 36 in the experimental group, and 31 in the control group.RESULTS: Over a six-month period, while the social skill scores of the children in the experimental and control groups increased, their violent behaviors decreased (p<.050). Increase in social skill scores and decrease in violent behaviors were higher in the experimental than in the control group children (p<.050). The parents in the experimental group stated that they had started to empathize with their children, using “I” language, and applied rules more consistently after the program.CONCLUSION: This program was successful in preventing violent behaviors in children through the development of social skills. Hence, it can be effectively implemented through a teacher/nurse collaboration.
Child ; Cooperative Behavior ; Humans ; Intelligence ; Non-Randomized Controlled Trials as Topic ; Nursing ; Parent-Child Relations ; Parents ; Social Skills ; Violence

PURPOSE: The purpose of this study was to investigate the effects of the ‘Becoming Happy I’ program on gratitude disposition, self-esteem, flow, and subjective happiness in nursing college students.METHODS: Participants in this study were 39 nursing college students (20 in the experimental group and 19 in the control group) at a college of nursing. The research design was a non-equivalent control group pretest-posttest as a quasi-experimental study. Data was collected from February to April in 2011 and analyzed via the SPSS/WIN 18.0 program with the χ² test, Fisher's exact test, repeated measures ANOVA, and Tukey HSD test.RESULTS: There were significant changes in gratitude disposition, self-esteem, flow, and subjective happiness in the experimental group before and after treatment, which was significantly different from the control group, and these effects lasted at a 4-week follow-up.CONCLUSION: The ‘Becoming Happy I’ program was effective in improving gratitude disposition, self-esteem, flow, and subjective happiness for nursing college students. As a result, we recommended that the ‘Becoming Happy I’ program be utilized as an effective intervention for nursing college students to improve gratitude disposition, self-esteem, flow, and subjective happiness.
Follow-Up Studies ; Happiness ; Humans ; Non-Randomized Controlled Trials as Topic ; Nursing ; Research Design ; Self Concept