Objective To summarize the role and implementation effect of risk management in Ophthalmic Day Surgery Center. Methods Since the establishment of Ophthalmic Day Surgery Center on October 8th, 2012, risk management was implemented in the aspects of hardware management, post setting, file management, operating process, service, etc., and the adverse events occurred in the period were analyzed to find out the defectiveness and hidden dangers in the working process, and then refined intervention measures were put forward and carried out. The surgical amount, occurrence of nosocomial infections and nursing adverse events, and patients satisfaction from October 8th, 2012 to June 30th, 2015 were analyzed. Results During this period, 52 073 ambulatory operations were completed, with no nosocomial infection and 2 cases of nursing adverse events. The patients satisfaction in 2013, 2014, and 2015 was 98.09%, 98.22%, and 99.85%, respectively. Conclusion The implementation of risk management in Ophthalmic Day Surgery Center can effectively reduce the occurrence of adverse events in nursing work, improve work efficiency, help to establish and improve the nursing security environment, improve the nurse-patient relationship, and improve patients satisfaction.
The Core Outcome Set-STAndards for Reporting (COS-STAR) is a latest guide tool made by Core Outcome Measures in Effectiveness Trials (COMET) group. It can enhance the transparency and completeness of Core Outcome Set (COS) report. This paper introduces the generation process, report items and application of COS-STAR to provide reference for domestic similar researches.
背景 通過確保對衛生服務使用者和其他特定領域衛生保健決策者關注的指標進行常規測量，核心指標集（core outcome set，COS）可以提高研究的相關性。到目前為止，已經形成了 200 多個 COS，但這些報告的透明度還不理想。如果 COS 的報告不夠完整和透明，COS 研究將無法實現其目標。 方法與結果 鑒于這些問題，由經驗豐富的 COS 制定者、方法學家、期刊編輯、COS 潛在用戶（臨床試驗者、系統評價員和臨床指南制定者）以及患者代表組成的一個國際性工作組，制定了核心指標集報告標準（Core Outcome Set-STAndards for Reporting，COS-STAR）聲明，作為 COS 研究報告的指南。其形成過程先后包括初始報告條目產生階段、代表關鍵利益相關方群體的 200 名人員的兩輪德爾菲問卷調查，最后是一個共識會議。COS-STAR 聲明由一個包含 18 個條目的清單組成，這些條目是確保所有 COS 研究報告透明度和完整性的必要條目。條目清單重點規范了形成特定 COS 的研究報告需涉及的前言、方法、結果和討論部分。COS-STAR 聲明的一個局限性在于其形成過程中缺乏低、中收入國家的代表性意見。而 COS 對在這些國家和地區開展的研究具有同等的相關性，故今后該指南可能需要不斷完善，以應對這些國家和地區 COS 形成的任何其他挑戰。 結論 隨著 COS 研究的不斷開展，COS-STAR 聲明將成為提高 COS 研究報告質量的有力工具，并使所有 COS 使用者受益。
Objective To evaluate the quality of randomized controlled trials (RCTs) of traditional Chinese medicine published inChinese Journal of Integrated Traditional and Western Medicine, and to analyze changes. Methods We searched CNKI to collect RCTs published inChinese Journal of Integrated Traditional and Western Medicine (CJITWM) in 2014. Reporting quality of RCTs was evaluated by using CONSORT 2010 checklist, the methodological quality and ethics requirements were also analyzed. The changes of quality was also analyzed by comparing with those of 2004. Results A total of 80 RCTs were included. The top three interventions were Chinese patent medicine, decoction, acupuncture. Items with high reporting rate (>80%) included abstract, participants, randomization sequences and informed consent. Items with reporting rate of 50% to 80% including introduction, interventions, harms and funding, and others were all less than 50%. Among them, the reporting quality of title, trial design, outcomes, sample size, type of randomization, allocation concealment, blinding, numbers analyzed, outcomes and estimation, generalizability, interpretation, registration and protocol was less than 10%. Compared with those of 2004, the quality of reporting, methodology, and ethics has all increased. Significant progress was made in items of structured summary, background and objectives, collecting participants, adverse reactions, quality control standards of TCM interventions, diagnostic evaluation criteria of TCM, follow-up, funding, ethical approval and informed consent. But small progress was made in randomization, allocation concealment and implementation, sample size, blinding and ITT. There has been no participant flow. Conclusion The quality of reporting, methodology, and ethics of RCTs published inChinese Journal of Integrated Traditional and Western Medicine have made some progress, however, trial design, outcomes selection, estimation of sample size, randomization, blinding, registration and participant flow are still needed to be further improved.
ObjectiveTo systematically evaluate the effectiveness of survival prediction models for lung cancer patients and analyze factors influencing model performance. MethodsRelevant literature was retrieved from PubMed, EMbase, China National Knowledge Infrastructure (CNKI), and Wanfang Data up to March 2025 using computerized searches. The risk of bias and applicability assessment tool for prognostic studies was applied to evaluate methodological quality and applicability of included studies. Meta-analysis was conducted using R software (version 4.4.3). ResultsA total of 11 studies involving 23134 patients published between 2017 and 2025 were included. Meta-analysis demonstrated a pooled C-index of 0.72 [95%CI (0.70, 0.74)] for lung cancer survival prediction models. Subgroup analysis revealed that studies with sample size >1,000 cases showed greater stability in model performance with a C-index of 0.72 [95%CI (0.71, 0.72)]; non-small cell lung cancer (NSCLC) models exhibited a C-index of 0.71 [95%CI (0.69, 0.73)] compared to small cell lung cancer (SCLC) models at 0.70 [95%CI (0.64, 0.76)]. Studies with survival rate <50% had a C-index of 0.71 [95%CI (0.69, 0.73)] while those with survival rate ≥50% showed 0.73 [95%CI (0.70, 0.75)], with no statistically significant difference between groups (P=0.2601). Tumor staging, surgical intervention, and chemotherapy were identified as key prognostic predictors. Risk of bias assessment indicated 7 studies with high or unclear risk of bias, 3 with low risk, though overall applicability remained satisfactory (only 1 study had unclear applicability). ConclusionLung cancer survival prediction models demonstrate good prognostic discrimination and calibration capabilities, but significant heterogeneity exists across models. Large sample size (>1000 patients) is crucial for reducing heterogeneity and improving stability. NSCLC models show slightly better predictive performance than SCLC models, with higher discriminative ability observed in populations with higher survival rates. Future research should focus on optimizing model design, minimizing bias risks, and enhancing both predictive accuracy and clinical utility.
ObjectivesTo investigate the status of clinical trial registrations (CTRs), ethical reviews (ERs) and informed consent forms (ICFs) of randomized controlled trials (RCTs), which were published in the top 20 journals included by Chinese Science Citation Database (CSCD), and evaluate the methodological quality of RCTs.MethodsWe selected top 20 high impact factor Chinese medical journals indexed by CSCD, the RCTs published between 2016 and 2017 were searched. The CTR, ER and ICFs for all RCTs were analyzed.ResultsA total of 395 RCTs were included for data analysis. Nineteen RCTs (4.8%) reported the information of registration. For the 4 traditional Chinese medicine journals, only 4 (1.9%) of 207 RCTs reported the registered information. For the 16 western medical journals, only 15 (8%) of 188 RCTs reported the registered information. There were 185 RCTs (46.8%) which reported the information of ethical review. Among them, 66 RCTs (31.9%) were published in traditional Chinese medical journals and 119 RCTs (63.3%) were published in western medical journals. There were 253 RCTs (64.1%) which reported the information of informed consent. Among them, 154 RCTs (74.4%) were published in Chinese medical journals and 199 RCTs (52.7%) were in western medical journals. In terms of methodology, approximately 299 RCTs (75.7%) reported the type of randomization where 60 RCTs (15.2%) reported the information of allocation concealment and 38 RCTs (59.6%) reported blinding.ConclusionsThe proportion of RCTs registration, ethical review and informed consent is still low and the methodological quality of the studies require to be improved. Therefore, it is necessary to strengthen the training of clinical trial methodology.
Objectives To systematically review the efficacy and safety of Yangzhengxiaoji capsule combined with chemotherapy for malignant digestive tract tumor. Methods CNKI, WanFang Data, PubMed, EMbase, SinoMed and The Cochrane Library databases were searched online to collect randomized controlled trials (RCTs) of Yangzhengxiaoji capsule combined with chemotherapy for malignant tumor of digestive tract from inception to November 20th, 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed using ReMan 5.3 software. Resluts A total of 15 RCTs were included. The results of meta-analysis showed that: compared with the chemotherapy alone, Yangzhengxiaoji capsule combined with chemotherapy could significantly improve the disease control rate (RR=1.26, 95%CI 1.07 to 1.49, P<0.000 01), the clinical efficacy of TCM syndrome (RR=1.71, 95%CI 1.50 to 1.96,P<0.000 01), and the quality of life scores of patients (RR=1.44, 95%CI 1.13 to 1.82,P=0.003). The combination therapy could also improve the immune function of patients and reduce the incidence of adverse reactions. Conclusions Current evidence shows that chemotherapy combined with Yangzhengxiaoji capsule is superior to chemotherapy alone for disease control of malignant tumor of digestive tract, clinical efficacy of TCM syndrome, the quality of life, and improving immune function. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.