METHODS: In this open-label, phase 3, multicentre randomised trial, patients aged 21-80 years with cT3 or cT4 gastric cancer undergoing curative resection were enrolled at 22 centres from South Korea, China, Japan, Malaysia, Hong Kong, and Singapore. Patients were randomly assigned to receive surgery and EIPL (EIPL group) or surgery alone (standard surgery group) via a web-based programme in random permuted blocks in varying block sizes of four and six, assuming equal allocation between treatment groups. Randomisation was stratified according to study site and the sequence was generated using a computer program and concealed until the interventions were assigned. After surgery in the EIPL group, peritoneal lavage was done with 1 L of warm (42°C) normal 0·9% saline followed by complete aspiration; this procedure was repeated ten times. The primary endpoint was overall survival. All analyses were done assuming intention to treat. This trial is registered with ClinicalTrials.gov, NCT02140034.
FINDINGS: Between Sept 16, 2012, and Aug 3, 2018, 800 patients were randomly assigned to the EIPL group (n=398) or the standard surgery group (n=402). Two patients in the EIPL group and one in the standard surgery group withdrew from the trial immediately after randomisation and were excluded from the intention-to-treat analysis. At the third interim analysis on Aug 28, 2019, the predictive probability of overall survival being significantly higher in the EIPL group was less than 0·5%; therefore, the trial was terminated on the basis of futility. With a median follow-up of 2·4 years (IQR 1·5-3·0), the two groups were similar in terms of overall survival (hazard ratio 1·09 [95% CI 0·78-1·52; p=0·62). 3-year overall survival was 77·0% (95% CI 71·4-81·6) for the EIPL group and 76·7% (71·0-81·5) for the standard surgery group. 60 adverse events were reported in the EIPL group and 41 were reported in the standard surgery group. The most common adverse events included anastomotic leak (ten [3%] of 346 patients in the EIPL group vs six [2%] of 362 patients in the standard surgery group), bleeding (six [2%] vs six [2%]), intra-abdominal abscess (four [1%] vs five [1%]), superficial wound infection (seven [2%] vs one [<1%]), and abnormal liver function (six [2%] vs one [<1%]). Ten of the reported adverse events (eight in the EIPL group and two in the standard surgery group) resulted in death.
INTERPRETATION: EIPL and surgery did not have a survival benefit compared with surgery alone and is not recommended for patients undergoing curative gastrectomy for gastric cancer.
FUNDING: National Medical Research Council, Singapore.
OBJECTIVE: This research aimed to examine the relationship between spiritual well-being and moral distress among a sample of Iranian nurses and also to study the determinant factors of moral distress and spiritual well-being in nurses.
RESEARCH DESIGN: A cross-sectional, correlational design was employed to collect data from 193 nurses using the Spiritual Well-Being Scale and the Moral Distress Scale-Revised.
ETHICAL CONSIDERATIONS: This study was approved by the Regional Committee of Medical Research Ethics. The ethical principles of voluntary participation, anonymity, and confidentiality were considered.
FINDINGS: Mean scores of spiritual well-being and moral distress were 94.73 ± 15.89 and 109.56 ± 58.70, respectively. There was no significant correlation between spiritual well-being and moral distress (r = -.053, p = .462). Marital status and job satisfaction were found to be independent predictors of spiritual well-being. However, gender and educational levels were found to be independent predictors for moral distress. Age, working in rotation shifts, and a tendency to leave the current job also became significant after adjusting other factors for moral distress.
DISCUSSION AND CONCLUSION: This study could not support the relationship between spiritual well-being and moral distress. However, the results showed that moral distress is related to many elements including individual ideals and differences as well as organizational factors. Informing nurses about moral distress and its consequences, establishing periodic consultations, and making some organizational arrangement may play an important role in the identification and management of moral distress and spiritual well-being.
METHODS: A questionnaire based on the Joint Commission International Accreditation Standards was electronically sent to 3 institutions each in 10 geographical regions across 9 Asian countries. Questions addressing 45 practices were divided into 3 categories. A five-tier scale with numerical scores was used to evaluate safety practices in each institution. Responses obtained from three institutions in the United States were used to validate the execution rate of each surveyed safety practice.
RESULTS: The institutional response rate was 70.0% (7 Asian regions, 21 institutions). 44 practices (all those surveyed except for the application of wrist tags for identifying patients with fall risks) were validated using the US participants. Overall, the Asian participants reached a consensus on 89% of the safety practices. Comparatively, most Asian participants did not routinely perform three pre-procedural practices in the examination appropriateness topic.
CONCLUSION: Based on the responses from 21 participating Asian institutions, most routinely perform standard practices during radiological examinations except when it comes to examination appropriateness. This study can provide direction for safety policymakers scrutinizing and improving regional standards of care.
ADVANCES IN KNOWLEDGE: This is the first multicenter survey study to elucidate pre-procedural safety practices in radiological examinations in seven Asian regions.
OBJECTIVE: We hypothesized that the risk of infections after primary cranioplasty in adult patients who underwent craniectomies for non-infection-related indications are no different when performed early or delayed. We tested this hypothesis in a prospective, multicenter, cohort study.
METHODS: Data were collected prospectively from 5 neurosurgical centers in the United Kingdom, Malaysia, Singapore, and Bangladesh. Only patients older than 16 years from the time of the non-infection-related craniectomy were included. The recruitment period was over 17 months, and postoperative follow-up was at least 6 months. Patient baseline characteristics, rate of infections, and incidence of hydrocephalus were collected.
RESULTS: Seventy patients were included in this study. There were 25 patients in the early cranioplasty cohort (cranioplasty performed before 12 weeks) and 45 patients in the late cranioplasty cohort (cranioplasty performed after 12 weeks). The follow-up period ranged between 16 and 34 months (mean, 23 months). Baseline characteristics were largely similar but differed only in prophylactic antibiotics received (P = 0.28), and primary surgeon performing cranioplasty (P = 0.15). There were no infections in the early cranioplasty cohort, whereas 3 infections were recorded in the late cohort. This did not reach statistical significance (P = 0.55).
CONCLUSIONS: Early cranioplasty in non-infection-related craniectomy is relatively safe. There does not appear to be an added advantage to delaying cranioplasties more than 12 weeks after the initial craniectomy in terms of infection reduction. There was no significant difference in infection rates or risk of hydrocephalus between the early and late cohorts.
STUDY DESIGN: A scoping review design was used.
METHODS: A systematic literature search was conducted using the Medline, CINAHL, AMED, Ageline, PsycINFO, Web of Sciences, Scopus, Thai-Journal Citation Index, MyCite and trial registries databases.
RESULTS: Thirty-seven studies and six study protocols were included, from Thailand, Malaysia, Singapore, Vietnam, Indonesia and the Philippines. One-sixth of the studies involved interventions, while the remainder were observational studies. The observational studies mainly determined the falls risk factors. The intervention studies comprised multifactorial interventions and single interventions such as exercises, educational materials and visual correction. Many of the studies replicated international studies and may not have taken into account features unique to Southeast Asia.
CONCLUSION: Our review has revealed studies evaluating falls and management of falls in the Southeast Asian context. More research is required from all Southeast Asian countries to prepare for the future challenges of managing falls as the population ages.
METHODS: At a regional meeting of the Asia Pacific Child and Family Health Alliance for Tobacco Control, members reviewed existing good practices of child-focused tobacco control approaches using health promotion strategies. These interventions were implemented nationally in Malaysia, the Philippines and Singapore.
RESULTS: Three good practice national examples were identified that focused on creating supportive tobacco-free environments and upgrading cessation skills among paediatricians. These country examples highlight strategic areas to protect children and families from the harms of tobacco, as part of NCD prevention and control. Training paediatricians in brief cessation advice has enabled them to address tobacco-using parents. Fully enforcing smoke-free public areas has led to an increase in smoke-free homes. The Tobacco Free Generation is a tobacco control 'endgame' strategy that taps into a social movement to deglamorize tobacco use and empower youth born in and after year 2000 to reject tobacco and nicotine addiction.
CONCLUSION: Tobacco control is pivotal in the fight against NCDs; health promotion strategies to protect children and youth from tobacco have a critical role to play in NCD prevention and control. Frontline health workers, including primary care paediatricians, need to step up and actively advocate for full implementation of the WHO Framework Convention on Tobacco Control, including tobacco tax increases and smoke-free areas, while monitoring patients and their parents for tobacco use and second-hand smoke exposure, preventing adolescent smoking uptake, and offering cessation support. A life-course approach incorporating child-focused efforts to prevent initiation of smoking and second-hand smoke exposure with measures promoting cessation among parents will offer the greatest chance of overcoming future tobacco-related NCD burden.