基于COSMIN指南对癌症患者支持性照护需求量表的系统评价

背景国内外用于评估癌症患者支持性照护需求的量表较多，但有关此类量表质量的标准化评价研究及不同量表间的横向比较研究较为缺乏，也少有研究者对此类量表的测量特性进行系统的整合与评价。目的评价中文版癌症患者支持性照护需求量表的测量学性能及研究的方法学质量。方法2021年4月检索中国知网、万方数据知识服务平台、维普中文科技期刊全文数据库、中国生物医学文献数据库、PubMed、EmBase、Web of Science、CINAHL Complete数据库，获取有关中文版癌症患者支持性照护需求量表测量学性能评价的研究，检索时限均为建库至2021年3月30日。由两位研究者独立筛选文献、提取资料后，采用健康测量工具遴选标准（COSMIN）系统综述指南，在对量表的测量特性及研究的方法学质量进行评价的基础上，综合评定中文版癌症患者支持性照护需求评估量表各测量特性的证据等级，并形成对于量表的最终推荐意见。采用描述分析法对评价结果进行汇总、分析。结果共纳入15项研究，涉及8个中文版癌症患者支持性照护需求评估量表〔癌症患者支持性照护需求简明问卷中文版（SCNS-SF34）、中文版支持性照护需求筛查工具（SCNS-ST9-C）、癌症患者综合需求评估量表（CNAT）、癌症需求简明问卷（CNQ-SF）、中文版癌症患者未满足需求量表（CaSUN-C）、癌症患者未满足需求简明量表（SF-SUNS）、晚期癌症患者需求评估问卷（ACNQ-41）、晚期癌症患者需求评估表简表（ACNQ-29）〕。就量表的测量特性质量而言，除ACNQ-29的内容效度为"未提及"外，其余7个量表的内容效度均为"不确定"；除CaSUN-C、SF-SUNS的结构效度为"充分"外，其余6个量表的结构效度均为"不确定"；SCNS-SF34、CNQ-SF、CaSUN-C、SF-SUNS的内部一致性为"充分"，ACNQ-41的内部一致性为"不充分"，其余3个量表的内部一致性为"不确定"；CNAT、CNQ-SF、ACNQ-29的假设检验为"未提及"，CaSUN-C、SF-SUNS、ACNQ-41的假设检验为"不确定"，SCNS-SF34、SCNS-ST9-C的假设检验为"充分"；除ACNQ-41的稳定性为"不充分"，SCNS-ST9-C、ACNQ-29的稳定性为"未提及"外，其余5个量表的稳定性均为"充分"；仅SCNS-SF34的跨文化效度为"充分"，其余7个量表的跨文化效度均为"未提及"。8个量表的推荐等级均为B级。结论SCNS-SF34的测量特性得到了最为全面的评价，其具有较好的信效度，且临床应用可行性高，可暂时被推荐使用，但上述结论仍有待更多高质量证据加以支撑。     

Practice developments supporting change implementation in Wellington,New Zealand (NZ) for ‘continuity of care when transitioning complex preterm infants from NICU to home’

The discussion paper will focus on continuity of care relating to previous NZ research, specifically to transitioning complex preterm infants from NICU to home based on parent experiences, and on the practice developments that have occurred, to ensure optimal health outcomes. Previous NZ research discovered parent desire a consistent service delivery for the entire transition journey from NICU and at home.An informative and comprehensive opportunity has occurred for reflective professional practice, evaluation, development and implementation which have transpired in positive change through innovative practice developments and support change implementation in Wellington, NZ. This has resulted in the articulation of a model of care that has both embraced and integrated parental desires for a continuity of care process for complex preterm infants. This has been achieved by having the same Discharge Facilitator/Key Case Manager present within the NICU and external to the NICU for Home-based infants for the entire transition journey.The paper will focus and emphasis additional practice development changes and furthermore, will present a real purpose, for other countries to learn of such practice developments that have exemplified a celebratory success for families of Wellington, NZ.     

Immunogenicity of two doses of BNT162b2 and mRNA-1273 vaccines for solid cancer patients on treatment with or without a previous SARS-CoV-2 infection

Previous studies on the immunogenicity of SARS-CoV-2 mRNA vaccines showed a reduced seroconversion in cancer patients. The aim of our study is to evaluate the immunogenicity of two doses of mRNA vaccines in solid cancer patients with or without a previous exposure to the virus. This is a single-institution, prospective, nonrandomized study. Patients in active treatment and a control cohort of healthy people received two doses of BNT162b2 (Comirnaty, BioNTech/Pfizer, The United States) or mRNA-1273 (Spikevax, Moderna). Vaccine was administered before starting anticancer therapy or on the first day of the treatment cycle. SARS-CoV-2 antibody levels against S1, RBD (to evaluate vaccine response) and N proteins (to evaluate previous infection) were measured in plasma before the first dose and 30 days after the second one. From January to June 2021, 195 consecutive cancer patients and 20 healthy controls were enrolled. Thirty-one cancer patients had a previous exposure to SARS-CoV-2. Cancer patients previously exposed to the virus had significantly higher median levels of anti-S1 and anti-RBD IgG, compared to healthy controls (P = .0349) and to cancer patients without a previous infection (P < .001). Vaccine type (anti-S1: P < .0001; anti-RBD: P = .0045), comorbidities (anti-S1: P = .0274; anti-RBD: P = .0048) and the use of G-CSF (anti-S1: P = .0151) negatively affected the antibody response. Conversely, previous exposure to SARS-CoV-2 significantly enhanced the response to vaccination (anti-S1: P < .0001; anti-RBD: P = .0026). Vaccine immunogenicity in cancer patients with a previous exposure to SARS-CoV-2 seems comparable to that of healthy subjects. On the other hand, clinical variables of immune frailty negatively affect humoral immune response to vaccination.     

Phase 1/2 clinical trial of COVID-19 vaccine in Japanese participants: A report of interim findings

We initiated a randomized, placebo-controlled, phase 1/2 trial to evaluate the safety and immunogenicity of the S-268019-b recombinant protein vaccine, scheduled as 2 intramuscular injections given 21 days apart, in 60 randomized healthy Japanese adults. We evaluated 2 regimens of the S-910823 antigen (5 μg [n = 24] and 10 μg [n = 24]) with an oil-in-water emulsion formulation and compared against placebo (n = 12). Reactogenicity was mild in most participants. No serious adverse events were noted. For both regimens, vaccination resulted in robust IgG and neutralizing antibody production at days 36 and 50 and predominant T-helper 1-mediated immune reaction, as evident through antigen-specific polyfunctional CD4+ T-cell responses with IFN-γ, IL-2, and IL-4 production on spike protein peptides stimulation. Based on the interim analysis, the S-268019-b vaccine is safe, produces neutralizing antibodies titer comparable with that in convalescent serum from COVID-19-recovered patients. However, further evaluation of the vaccine in a large clinical trial is warranted.     

Defining Textbook Outcome in liver surgery and assessment of hospital variation: A nationwide population-based study

IntroductionTextbook outcome (TO) is a composite outcome measure covering the surgical care process in a single outcome measure. TO has an advantage over single outcome parameters with low event rates, which have less discriminating impact to detect differences between hospitals. This study aimed to assess factors associated with TO, and evaluate hospital and network variation after case-mix correction in TO rates for liver surgery.MethodsThis was a population-based retrospective study of all patients who underwent liver resection for malignancy in the Netherlands in 2019 and 2020. TO was defined as absence of severe postoperative complications, mortality, prolonged length of hospital stay, and readmission, and obtaining adequate resection margins. Multivariable logistic regression was used for case-mix adjustment.Results2376 patients were included. TO was accomplished in 1380 (80%) patients with colorectal liver metastases, in 192 (76%) patients with other liver metastases, in 183 (74%) patients with hepatocellular carcinoma and 86 (51%) patients with biliary cancers. Factors associated with lower TO rates for CRLM included ASA score ≥3 (aOR 0.70, CI 0.51–0.95 p = 0.02), extrahepatic disease (aOR 0.64, CI 0.44–0.95, p = 0.02), tumour size >55 mm on preoperative imaging (aOR 0.56, CI 0.34–0.94, p = 0.02), Charlson Comorbidity Index ≥2 (aOR 0.73, CI 0.54–0.98, p = 0.04), and major liver resection (aOR 0.50, CI 0.36–0.69, p < 0.001). After case-mix correction, no significant hospital or oncological network variation was observed.ConclusionTO differs between indications for liver resection and can be used to assess between hospital and network differences.     

Home Use Guidance for Aerosol-Generating Procedures During the Coronavirus Disease 2019 Pandemic

From the early days of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, there were concerns that nebulizers used for the treatment of respiratory diseases as aerosol-generating devices could enhance the transmission of SARS-CoV-2. However, given the absence of any compelling data showing that nebulized treatments increase the risk of SARS-CoV-2 infection, it is unnecessary for community-dwelling patients with respiratory diseases to alter their current therapies, including nebulized treatments, to prevent symptom exacerbations. Maintaining current inhaled therapies also minimizes the risk of hospitalization and hospital-acquired infection of SARS-CoV-2.     

基于CiteSpace的足三里穴研究可视化分析＊

目的 围绕足三里穴（ST36）进行文献可视化分析，探索近20年来有关足三里穴的研究进程、热点以及未来发展趋势。方法 以中国知网（CNKI）为数据来源，利用citespace软件对检索出的2000年1月至2021年11月收录的基础研究和临床研究文献分别进行可视化分析，绘制关键词、作者、机构相关图谱。结果 基础研究纳入1030篇文献，得到9个关键词聚类，电针中心度最高（0.53），发文量最多的作者是胡森（22篇），发文量最大的机构是北京中医药大学针灸推拿学院（23篇）。临床研究纳入2067篇文献，得到9个关键词聚类，穴位注射和针刺中心度最高（0.27），发文量最多的作者是张波（7篇），发文量最大的机构是浙江中医药大学附属第一医院（8篇）。结论 足三里穴在基础和临床的研究重点、热点和趋势不一致。并且在基础研究和临床研究之间，针刺镇痛、电针疗法、胃肠功能这三个内容是同步的，而关于代谢组学、穴位注射、温针灸和揿针的内容则是脱节的。     

中医药预防结直肠癌术后复发转移的临床研究述评＊

对于结直肠癌患者，术后复发转移是导致其死亡的主要原因。大量研究显示中医药在结直肠癌复发转移的预防方面有着良好疗效。本文从临床研究入手，针对疾病不同分期，从结直肠癌术后辨证分型的临床研究及中医药预防结直肠癌复发转移的临床试验研究两方面展开论述，发现问题并给出未来临床研究方向的建议。本文旨在为结直肠癌术后复发转移中医药预防的临床研究提供思路和方法，把控好中医药在结直肠癌全过程防治中关键环节，更好地继承发扬中医药在“治未病”中的独特优势。     

Impact of COVID-19 and malaria coinfection on clinical outcomes: a retrospective cohort study

ObjectivesDespite the possibility of concurrent infection with COVID-19 and malaria, little is known about the clinical course of coinfected patients. We analysed the clinical outcomes of patients with concurrent COVID-19 and malaria infection.MethodsWe conducted a retrospective cohort study that assessed prospectively collected data of all patients who were admitted between May and December 2020 to the Universal COVID-19 treatment center (UCTC), Khartoum, Sudan. UCTC compiled demographic, clinical, laboratory (including testing for malaria), and outcome data in all patients with confirmed COVID-19 hospitalized at that clinic. The primary outcome was all-cause mortality during the hospital stay. We built proportional hazard Cox models with malaria status as the main exposure and stepwise adjustment for age, sex, cardiovascular comorbidities, diabetes, and hypertension.ResultsWe included 591 patients with confirmed COVID-19 diagnosis who were also tested for malaria. Mean (SD) age was 58 (16.2) years, 446/591 (75.5%) were males. Malaria was diagnosed in 270/591 (45.7%) patients. Most malaria patients were infected by Plasmodium falciparum (140/270; 51.9%), while 121/270 (44.8%) were coinfected with Plasmodium falciparum and Plasmodium vivax. Median follow-up was 29 days. Crude mortality rates were 10.71 and 5.87 per 1000 person-days for patients with and without concurrent malaria, respectively. In the fully adjusted Cox model, patients with concurrent malaria and COVID-19 had a greater mortality risk (hazard ratio 1.43, 95% confidence interval 1.21-1.69).DiscussionCoinfection with COVID-19 and malaria is associated with increased all-cause in-hospital mortality compared to monoinfection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).