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*

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: 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

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*

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

STUDY DESIGN: A quasi-experimental single-blinded study. PURPOSE: To investigate the effects of ‘graded exercise integrated with education’ on physical fitness, exercise self-efficacy (ESE), and physical activity (PA) levels among subacute and chronic wheelchair-dependent paraplegia patients. OVERVIEW OF LITERATURE: Most of the chronic spinal cord injury (SCI) patients had low physical fitness due to a sedentary lifestyle and lack of ESE after discharge from a rehabilitation program. Education may encourage them to engage with exercise to regain and maintain their physical fitness. However, there is a lack of research to support the effects of exercise integrated with education after an SCI. METHODS: A total of 44 participants will be assigned to either the experimental group (graded exercise integrated with education) or active control (conventional physical therapy). The experimental group will receive graded strength and aerobic exercise training according to their progression criteria. They will attend an education program during and after the rehabilitation program. The control group will only receive conventional physical therapy during their in-rehabilitation program. This study will be conducted during a period of 16 weeks, consisting of 8 weeks of in-rehabilitation and 8 weeks post-rehabilitation. Statistical analysis will be performed using the IBM SPSS ver. 21.0 (IBM Corp., Armonk, NY, USA) at a significance level of p≤0.05. RESULTS: The primary outcome measures will be upper-limb isokinetic strength, isometric grip strength, and cardiorespiratory fitness. The secondary outcomes will be ESE and PA levels. CONCLUSIONS: An intervention that combines exercise training and education may be warranted to enhance the physical fitness, ESE, and PA levels in SCI patients. This trial was registered with ClinicalTrials.gov (NCT03420170).
Education ; Exercise ; Hand Strength ; Health Education ; Humans ; Motor Activity ; Non-Randomized Controlled Trials as Topic ; Outcome Assessment (Health Care) ; Paraplegia ; Physical Fitness ; Rehabilitation ; Sedentary Lifestyle ; Self Efficacy ; Spinal Cord Injuries ; Spinal Cord ; Spine

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