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Comparison of the aetiology, microbiological isolates and antibiotic susceptibilities of endophthalmitis between children and adults in southern China: a retrospective, cohort study. 中国南方儿童和成人眼底病病因、微生物分离物和抗生素敏感性的比较:一项回顾性队列研究。
IF 2.4 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-13 DOI: 10.1136/bmjopen-2024-085021
Yao Yang, Jiaqi Lin, Yujie Li, Xiaohu Ding, Manli Liu, Jieting Zeng, Xiaofeng Lin, Fang Duan

Objectives: To compare aetiology, microbiological isolates and antibiotic susceptibilities of endophthalmitis between children and adults.

Design: Retrospective observational study.

Participants: Patients admitted to Zhongshan Ophthalmic Center between January 2013 and December 2019 with clinically diagnosed endophthalmitis were included.

Outcome measures: The aetiology, microbiological isolates and antibiotic susceptibilities of endophthalmitis were analysed.

Results: Of 1803 patients, 430 (23.8%) were aged ≤16 years. In both children and adults, the main aetiology was trauma (85.6% vs 64.7%, p<0.05). Streptococcus species (spp.) (28.8%) were most prevalent in paediatric post-traumatic endophthalmitis; whereas, coagulase-negative staphylococci (36.9%) were dominant in adults. In postoperative endophthalmitis, all children had bacterial infections, while fungal infections accounted for 12.5% in adults. In endogenous endophthalmitis caused by fungi, Candida was most prevalent in adults (26.9%); whereas, all causative fungi involved filamentous fungi in children. Isolated bacteria in children presented a higher susceptibility in 7 of 11 antibiotics compared with those in adults. Levofloxacin had the highest susceptibility rate in children (97.9%), and ofloxacin had the highest susceptibility rate in adults (90.6%).

Conclusion: The main aetiology was trauma, with a higher proportion in children than in adults. The microbial profile of paediatric endophthalmitis was different from those of adults. Susceptibilities of causative bacteria to most antibiotics were higher in children than in adults.

目的:比较儿童和成人眼内炎的病因、微生物分离和抗生素敏感性:比较儿童和成人眼内炎的病因、微生物分离物和抗生素敏感性:回顾性观察研究:结果测量:分析眼底病的病因、微生物分离物和抗生素敏感性:结果:在 1803 名患者中,430 人(23.8%)的年龄小于 16 岁。在儿童和成人中,主要病因都是外伤(85.6% 对 64.7%),在儿童外伤后眼内炎中最常见的是链球菌(28.8%),而在成人中则主要是凝固酶阴性葡萄球菌(36.9%)。在术后眼内炎中,所有儿童均为细菌感染,而成人中真菌感染占 12.5%。在由真菌引起的内源性眼内炎中,念珠菌在成人中最常见(26.9%);而在儿童中,所有致病真菌均为丝状真菌。在 11 种抗生素中,儿童对其中 7 种的敏感性高于成人。儿童对左氧氟沙星的敏感率最高(97.9%),成人对氧氟沙星的敏感率最高(90.6%):结论:主要病因是外伤,儿童的比例高于成人。儿童眼内炎的微生物特征与成人不同。儿童对大多数抗生素的敏感性高于成人。
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引用次数: 0
Trends and patterns of antimicrobial consumption at Benjamin Mkapa Zonal Referral Hospital, Dodoma, Tanzania: a cross-sectional retrospective analysis. 坦桑尼亚多多马本杰明-姆卡帕地区转诊医院的抗菌药消耗趋势和模式:横断面回顾性分析。
IF 2.4 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-13 DOI: 10.1136/bmjopen-2023-083842
Kauke Bakari Zimbwe, Yusto Julius Yona, Charity Alphonce Chiwambo, Alphonce Bilola Chandika, Humphrey Sawira Kiwelu, Moshi Moshi Shabani

Objective: This study assessed the trends and patterns of antimicrobial consumption (AMC) from 2020 to 2021, 2021-2022 and 2022-2023 at the Benjamin Mkapa Zonal Referral Hospital (BMH) in Dodoma, Tanzania.

Design: A retrospective cross-sectional study was conducted to collect AMC data for three financial years with respective denominators. The data were computed using the AMC Tool 2019 v1.9.0 and defined daily dose per 1000 inhabitants per day (DID).

Setting: The BMH, Dodoma, Tanzania.

Participants: This study surveyed quantities of antimicrobials procured at the BMH. It did not have any human participants.

Outcome measures: AMC was quantified in DID. The comparisons were made based on the DID of all surveyed antimicrobials, taking into account oral and parenteral administration and based on pharmacological classes. Further, DIDs were presented based on the 2023 WHO Access (A), Watch (W) and Reserve (R) (AWaRe) classification.

Results: In 29 assessed antimicrobials, the DIDs for 2020-2021, 2021-2022 and 2022-2023 were 3.0852, 3.5892 and 3.9213, respectively. The average DID per year was 3.5319, with a mean of 2.4207±1.9765 DID per year. The topmost consumed antimicrobials over the 3 years (doxycycline, azithromycin, amoxicillin/beta-lactamase inhibitors, ampicillin/cloxacillin, amoxicillin/flucloxacillin, ceftriaxone, nitrofurantoin and clarithromycin) account over 90% of consumption. The most highly consumed therapeutic classes were beta-lactam antibacterial penicillins (34.71%), macrolides, lincosamides, streptogramins and others (25.75%), followed by tetracycline (23.88%). The AWaRe categorisation and antimicrobials not recommended (ANR) distribution were as follows: Access-51.61%, Watch-31.96%, Reserve-0.00%, and ANR-16.43%, respectively.

Conclusion: For every 1000 patients attending the BMH per day, our study found 2.4207±1.9765 DIDs of an antimicrobial were consumed. The most consumed antimicrobials include doxycycline, azithromycin, amoxicillin/beta-lactamase inhibitor, ceftriaxone and metronidazole. To combat antimicrobial resistance effectively, it is imperative to institute a hospital policy for antimicrobial stewardship that prioritises the utilisation of a hospital formulary and antibiograms for the procurement of antimicrobials at the BMH.

研究目的本研究评估了坦桑尼亚多多马本杰明-姆卡帕地区转诊医院(BMH)2020-2021年、2021-2022年和2022-2023年抗菌药物消耗量(AMC)的趋势和模式:进行了一项回顾性横断面研究,收集了三个财政年度的AMC数据,并分别列出了分母。数据使用AMC工具2019 v1.9.0计算,并定义了每1000名居民每天的日剂量(DID):坦桑尼亚多多马的 BMH:本研究调查了 BMH 采购抗菌药物的数量。结果测量:AMC以DID量化。根据所有调查抗菌药物的 DID 进行比较,同时考虑到口服和肠外给药以及药理类别。此外,还根据 2023 年世界卫生组织的准入(A)、观察(W)和储备(R)(AWaRe)分类法列出了 DID:结果:在 29 种接受评估的抗菌药物中,2020-2021 年、2021-2022 年和 2022-2023 年的 DID 分别为 3.0852、3.5892 和 3.9213。平均每年 DID 为 3.5319,平均每年 DID 为 2.4207±1.9765。三年中消费量最大的抗菌药物(强力霉素、阿奇霉素、阿莫西林/β-内酰胺酶抑制剂、氨苄西林/环丙西林、阿莫西林/氟氯西林、头孢曲松、硝基呋喃妥因和克拉霉素)占消费量的 90%以上。消耗量最大的治疗类药物是β-内酰胺类抗菌青霉素(34.71%)、大环内酯类、林可酰胺类、链霉素及其他(25.75%),其次是四环素(23.88%)。AWaRe分类和不推荐使用的抗菌药物(ANR)分布情况如下:获得-51.61%,观察-31.96%,保留-0.00%,不推荐-16.43%:我们的研究发现,每天每 1000 名在 BMH 就诊的患者中,就有 2.4207±1.9765 DIDs 的抗菌药物被消耗。消耗最多的抗菌药物包括强力霉素、阿奇霉素、阿莫西林/β-内酰胺酶抑制剂、头孢曲松和甲硝唑。为了有效对抗抗菌素耐药性,必须制定医院抗菌素管理政策,优先使用医院处方集和抗生素图谱来采购抗菌素。
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引用次数: 0
Global trends in the burden of rheumatoid arthritis by sociodemographic index: a joinpoint and age-period-cohort analysis based on the Global Burden of Disease Study 2019. 按社会人口指数划分的类风湿关节炎负担的全球趋势:基于《2019 年全球疾病负担研究》的连接点和年龄段队列分析。
IF 2.4 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-12 DOI: 10.1136/bmjopen-2023-082966
Cheng Chen, QiLin Shi, WenBao He, HaoJun Tian, TianBao Ye, YunFeng Yang

Objective: To describe temporal trends in the incidence and disability-adjusted life years (DALYs) of rheumatoid arthritis (RA) across sociodemographic index (SDI) quintiles and sexes from 1990 to 2019.

Methods: Data on RA incidence and DALYs with a 95% uncertainty interval from 1990 to 2019 were extracted from the Global Burden of Disease 2019. Subsequently, trends across SDI quintiles and sexes from 1990 to 2019 were determined using joinpoint regression and age-period-cohort analyses.

Results: A significant upward trend in the global age-standardised incidence rate (ASIR) of RA was observed for both sexes from 1990 to 2019 (average annual per cent change (AAPC): 0.214, 95% CI 0.179 to 0.249, p<0.001). Specifically, the ASIR of RA for both sexes demonstrated a significant increasing trend at all SDI levels, with the highest AAPC observed in the low SDI regions. A non-significant increasing trend in the global age-standardised DALYs rate (ASDR) of RA was observed for both sexes from 1990 to 2019 (AAPC: 0.017, 95% CI -0.051 to 0.085, p=0.621). Varying trends in ASDR were observed for both sexes and across SDI quintiles. Additionally, diverse age-period-cohort patterns in incidence and DALYs were observed across SDI quintiles and sexes.

Conclusion: The significant heterogeneity observed in the temporal trends of the incidence and DALYs of RA across SDI quintiles and sexes suggests potential disparities in the prevention, management and treatment of RA. Therefore, establishment of practical and customised healthcare initiatives for specific populations across SDI quintiles and sexes and allocation of supplementary health resources to high-risk populations are crucial for effective management of RA.

目的描述1990年至2019年不同社会人口指数(SDI)五分位数和性别的类风湿关节炎(RA)发病率和残疾调整生命年(DALYs)的时间趋势:从《2019 年全球疾病负担》中提取了 1990 年至 2019 年的类风湿关节炎发病率和残疾调整寿命年数数据以及 95% 的不确定区间。随后,利用连接点回归和年龄-时期-队列分析确定了1990年至2019年SDI五分位数和性别的趋势:结果:从 1990 年到 2019 年,男女性 RA 的全球年龄标准化发病率(ASIR)均呈明显上升趋势(年均百分比变化(AAPC):0.214,95% C%):0.214, 95% CI 0.179 to 0.249, p结论:在SDI五分位数和性别之间观察到的RA发病率和残疾调整寿命年数的时间趋势存在明显的异质性,这表明在RA的预防、管理和治疗方面可能存在差异。因此,针对不同SDI五分位数和性别的特定人群制定切实可行的定制医疗保健措施,并为高风险人群分配补充医疗资源,对于有效管理RA至关重要。
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引用次数: 0
Association of relationship satisfaction with blood pressure: a cross-sectional study of older adults in rural Burkina Faso. 人际关系满意度与血压的关系:对布基纳法索农村老年人的横断面研究。
IF 2.4 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-12 DOI: 10.1136/bmjopen-2024-089374
Felicitas Maria Jaspert, Guy Harling, Ali Sie, Mamadou Bountogo, Till Bärnighausen, Beate Ditzen, Melanie Sandy Fischer

Objectives: The objective of this study is to examine the association between relationship satisfaction and blood pressure (BP) in a low-income setting and to screen for gender moderation in this context. Research conducted in high-income settings suggests that relationship satisfaction is associated with better physical and mental health outcomes.

Design: A cross-sectional study design was employed, using both questionnaire and physical measurement data. Multiple linear regression models were calculated for systolic and diastolic BP and adjusted for age, gender, demographics/socioeconomics and other health-related variables. Gender moderation was tested using interaction terms in multivariable analyses.

Setting: A household survey was conducted in 2018 in rural northwestern Burkina Faso.

Participants: Final analysis included 2114 participants aged over 40 who were not pregnant, reported being in a partnership and had valid BP readings.

Main outcome measures: Systolic and diastolic BP levels.

Results: A significant positive association existed between relationship satisfaction (Couples Satisfaction Index-4 score) and systolic BP (B=0.23, 95% CI (0.02 to 0.45), p=0.03) when controlling for demographics/socioeconomics. Nevertheless, this relationship lost statistical significance when additional adjustments were made for health-related variables (B=0.21, 95% CI (-0.01 to 0.42), p=0.06). There was no significant association of relationship satisfaction and diastolic BP and no evidence of gender moderation.

Conclusion: In contrast to many higher-income settings, we found a positive association between relationship satisfaction and systolic BP in very low-income rural Burkina Faso. Our results add to the evidence regarding the contextual nature of the association between relationship satisfaction and health, as high relationship satisfaction may not act as a health promotor in this socioeconomic context.

研究目的本研究的目的是在低收入环境中研究人际关系满意度与血压(BP)之间的关系,并在此背景下筛查性别调节因素。在高收入环境中进行的研究表明,人际关系满意度与更好的身心健康结果有关:设计:采用横断面研究设计,同时使用问卷调查和身体测量数据。计算了收缩压和舒张压的多元线性回归模型,并对年龄、性别、人口统计学/社会经济学和其他健康相关变量进行了调整。在多变量分析中使用交互项检验了性别调节作用:2018年在布基纳法索西北部农村地区进行了一次家庭调查:主要结果测量指标:收缩压和舒张压:收缩压和舒张压水平:结果:在控制了人口统计学/社会经济学因素后,关系满意度(夫妇满意度指数-4评分)与收缩压之间存在明显的正相关(B=0.23,95% CI (0.02 to 0.45),P=0.03)。然而,在对健康相关变量进行额外调整后,这种关系失去了统计学意义(B=0.21,95% CI (-0.01 to 0.42),p=0.06)。人际关系满意度与舒张压无明显关联,也无证据表明存在性别调节:与许多高收入国家不同,我们发现在布基纳法索低收入农村地区,人际关系满意度与收缩压之间存在正相关。我们的研究结果为关系满意度与健康之间关系的背景性质提供了更多证据,因为在这种社会经济背景下,高关系满意度可能不会起到促进健康的作用。
{"title":"Association of relationship satisfaction with blood pressure: a cross-sectional study of older adults in rural Burkina Faso.","authors":"Felicitas Maria Jaspert, Guy Harling, Ali Sie, Mamadou Bountogo, Till Bärnighausen, Beate Ditzen, Melanie Sandy Fischer","doi":"10.1136/bmjopen-2024-089374","DOIUrl":"https://doi.org/10.1136/bmjopen-2024-089374","url":null,"abstract":"<p><strong>Objectives: </strong>The objective of this study is to examine the association between relationship satisfaction and blood pressure (BP) in a low-income setting and to screen for gender moderation in this context. Research conducted in high-income settings suggests that relationship satisfaction is associated with better physical and mental health outcomes.</p><p><strong>Design: </strong>A cross-sectional study design was employed, using both questionnaire and physical measurement data. Multiple linear regression models were calculated for systolic and diastolic BP and adjusted for age, gender, demographics/socioeconomics and other health-related variables. Gender moderation was tested using interaction terms in multivariable analyses.</p><p><strong>Setting: </strong>A household survey was conducted in 2018 in rural northwestern Burkina Faso.</p><p><strong>Participants: </strong>Final analysis included 2114 participants aged over 40 who were not pregnant, reported being in a partnership and had valid BP readings.</p><p><strong>Main outcome measures: </strong>Systolic and diastolic BP levels.</p><p><strong>Results: </strong>A significant positive association existed between relationship satisfaction (Couples Satisfaction Index-4 score) and systolic BP (B=0.23, 95% CI (0.02 to 0.45), p=0.03) when controlling for demographics/socioeconomics. Nevertheless, this relationship lost statistical significance when additional adjustments were made for health-related variables (B=0.21, 95% CI (-0.01 to 0.42), p=0.06). There was no significant association of relationship satisfaction and diastolic BP and no evidence of gender moderation.</p><p><strong>Conclusion: </strong>In contrast to many higher-income settings, we found a positive association between relationship satisfaction and systolic BP in very low-income rural Burkina Faso. Our results add to the evidence regarding the contextual nature of the association between relationship satisfaction and health, as high relationship satisfaction may not act as a health promotor in this socioeconomic context.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142614637","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Study of a brief online and group focusing intervention: a protocol for a randomised clinical trial. 简短在线和小组集中干预研究:随机临床试验方案。
IF 2.4 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-12 DOI: 10.1136/bmjopen-2023-080094
Clara Aguiar, Cláudia Oliveira, Marina Monteiro, Alexandra Paiva, João Salgado

Introduction: Emotion dysregulation is a transdiagnostic characteristic that affects many people with many psychopathological problems. Two mechanisms that have been frequently associated with emotional regulation are immersion and distancing. Focusing is a task that combines these two mechanisms of emotion regulation through the phase of creating a working distance and subsequently the phase of reassigning meaning. However, the benefit of its use in Portuguese population without a moderate to severe symptomatology for promoting mental health remains unclear.

Methods and analysis: Participants aged between 18 and 65 years who wish to improve their awareness and understanding of their emotions will be recruited and then, randomised into two groups: the intervention group (IG) and the control group (CG; delayed intervention). The IG will have access to two focusing sessions and the CG will only have access to the intervention 4 weeks later. Both groups will be evaluated at five different times. Primary outcomes include positive and negative affect, attitudes towards focusing (emotions and bodily sensations), the ability to perform focusing and emotion regulation. Secondary outcomes include mental health and psychological well-being, depression and anxiety symptoms and self-esteem.

Ethics and dissemination: Our study has been approved by the Council of Ethics and Deontology of the University of Maia. Findings will be disseminated via manuscripts, presentations and the lead author's thesis.

Trial registration number: ISRCTN16974329.

简介情绪失调是一种跨诊断的特征,影响着许多有心理病理问题的人。与情绪调节经常相关的两种机制是沉浸和疏远。通过建立工作距离阶段和随后的重新分配意义阶段,聚焦是一项结合了这两种情绪调节机制的任务。然而,在没有中重度症状的葡萄牙人群中使用该方法对促进心理健康的益处仍不明确:将招募年龄在 18 岁至 65 岁之间、希望提高对自身情绪的认识和理解的参与者,然后将其随机分为两组:干预组(IG)和对照组(CG;延迟干预)。干预组将接受两次集中训练,而对照组只能在 4 周后接受干预。两组都将在五个不同的时间接受评估。主要结果包括积极和消极情绪、对集中注意力的态度(情绪和身体感觉)、进行集中注意力的能力和情绪调节能力。次要结果包括精神健康和心理健康、抑郁和焦虑症状以及自尊:我们的研究已获得马亚大学伦理与道德委员会的批准。研究结果将通过手稿、演讲和主要作者的论文进行传播。试验注册号:ISRCTN16974329。
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引用次数: 0
Different interventions to prevent preterm birth in pregnant women with cervical shortening during pregnancy: a protocol for a network meta-analysis. 预防孕期宫颈缩短孕妇早产的不同干预措施:网络荟萃分析方案。
IF 2.4 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-12 DOI: 10.1136/bmjopen-2024-084015
JieFeng Luo, Dan Liu, Jiyong Liu

Introduction: Premature birth is the leading cause of neonatal mortality. Cervical length shortening during pregnancy serves as the gold standard for predicting preterm birth. Although several interventions have been applied to reduce the incidence of preterm birth in short cervix pregnant women, the optimal intervention in clinical practice remains controversial. The aim of this study is to conduct a network meta-analysis to explore the optimal intervention for preventing preterm birth among pregnant women with a short cervix.

Methods and analysis: We will search electronic information databases including PubMed, Embase Ovid, Cochrane Library Ovid, Wanfang Data, China Science and Technology Journal Database(VIP) and clinical trial registry websites (US Clinical Trials Registry and China Clinical Trials Registry) until 1 January 2024. Randomised controlled trials (RCTs) comparing two or more interventions to prevent preterm birth in short cervix pregnant women will be included. The primary outcomes are preterm birth rate at <37 weeks and the composite neonatal adverse outcome, secondary outcomes include spontaneous preterm birth rate at <37 weeks, preterm birth rate at <34 weeks, spontaneous preterm birth rate at <34 weeks, week of gestation, birth weight of the newborn, perinatal mortality and neonatal admission rate. Risk of bias 2.0 (ROB 2.0) will be used to assess the risk of bias in the RCT, and the Confidence in Network Meta-Analysis software will be used to assess the certainty of the generated evidence. The network meta-analysis will be conducted using the gemtc package in R 4.2.2. Two investigators independently performed article screening, data extraction and quality assessment. In addition, subgroup analyses and sensitivity analyses will be used to assess the robustness of the findings.

Ethics and dissemination: Ethical considerations will not be required. Results will be published in a peer-review journal.

Prospero registration number: CRD42022315200.

引言早产是新生儿死亡的主要原因。孕期宫颈长度缩短是预测早产的金标准。虽然已有多种干预措施用于降低短宫颈孕妇的早产率,但临床实践中的最佳干预措施仍存在争议。本研究旨在进行网络荟萃分析,探讨预防宫颈短孕妇早产的最佳干预措施:我们将检索电子信息数据库,包括PubMed、Embase Ovid、Cochrane Library Ovid、万方数据、中国科技期刊数据库(VIP)和临床试验注册网站(美国临床试验注册中心和中国临床试验注册中心),直至2024年1月1日。将纳入比较两种或两种以上预防短宫颈孕妇早产干预措施的随机对照试验(RCT)。主要结果是伦理和传播方面的早产率:无需考虑伦理因素。研究结果将发表在同行评审期刊上:CRD42022315200。
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引用次数: 0
Assessing if motives-based vignettes influence plans for drinking and alcohol cues: protocol for a randomised controlled trial. 评估基于动机的小故事是否会影响饮酒计划和酒精线索:随机对照试验方案。
IF 2.4 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-12 DOI: 10.1136/bmjopen-2024-086437
Joel Crawford, Elizabeth Collier, Richard Cooke, Katarina Ulfsdotter Gunnarsson, Gillian Shorter, Marcus Bendtsen

Introduction: In Sweden and the UK, there is a high prevalence of risky drinking, a pattern of drinking associated with adverse consequences. Drinking motives are a proximal predictor of risky drinking and subsequent consequences, suggesting it may be an apt intervention target. Currently, there is a lack of evidence regarding the applicability of motives for intervention efforts. The current study aims to test if motives-based materials are effective in impacting plans for future drinking and reactivity to alcohol-related cues. A secondary aim is to assess individuals' perceptions of risky drinking as outlined by health authorities. The results of the study will inform the design of a motives-based digital alcohol intervention.

Methods and analysis: The study is a three-arm, parallel group, randomised controlled trial. Vignettes will be used to present health information, framed in terms of gains from limiting drinking and losses from excess drinking. Control vignettes will present general health information framed in terms of gains or losses. Proxies for behaviour (intentions and self-efficacy) will be assessed with questionnaire items. A Stroop task will be used to assess reactivity to alcohol cues, and an open-ended item will be used to record perceptions of risky drinking. Outcomes will be contrasted with regression models and estimated using Bayesian inference, while qualitative data will be analysed using thematic analysis within a framework analysis.

Ethics and dissemination: Ethical approval for the study was waived by the Swedish Ethical Review Authority on 16 December 2023 based on participants being anonymous (Dnr. 2023-06474-01). The results of the study will be disseminated in an academic journal and research conferences while also informing the design of a national digital alcohol intervention.

Trial registration number: ISRCTN12456514.

导言:在瑞典和英国,危险饮酒的发生率很高,这是一种与不良后果相关的饮酒模式。饮酒动机是危险饮酒及其后果的近端预测因素,这表明它可能是一个合适的干预目标。目前,关于动机对干预工作的适用性还缺乏证据。本研究旨在测试基于动机的材料是否能有效影响未来的饮酒计划和对酒精相关线索的反应。另一个目的是评估个人对卫生部门提出的危险饮酒的看法。研究结果将为设计基于动机的数字酒精干预措施提供参考:该研究是一项三臂、平行分组、随机对照试验。小故事将用于介绍健康信息,框架为限制饮酒带来的收益和过量饮酒带来的损失。对照小故事将介绍一般健康信息,以收益或损失为框架。行为代用指标(意向和自我效能感)将通过问卷项目进行评估。斯特罗普任务将用于评估对酒精线索的反应,开放式项目将用于记录对危险饮酒的看法。研究结果将与回归模型进行对比,并使用贝叶斯推理方法进行估算,而定性数据将在框架分析中使用主题分析法进行分析:瑞典伦理审查机构于 2023 年 12 月 16 日以参与者匿名为由免除了本研究的伦理审批(Dnr.)研究结果将在学术期刊和研究会议上发布,同时也将为全国数字酒精干预措施的设计提供参考。试验注册号:ISRCTN12456514。
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引用次数: 0
Oxygen extraction-guided transfusion strategy in critically ill patients: study protocol for a randomised, open-labelled, controlled trial. 重症患者以抽氧为指导的输血策略:随机、开放标签对照试验的研究方案。
IF 2.4 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-12 DOI: 10.1136/bmjopen-2024-089910
Alberto Fogagnolo, Danila Azzolina, Fabio Silvio Taccone, Emma Pedarzani, Gianluca Pasa, Daniele Marianello, Giorgia Valpiani, Chiara Marchesini, Filippo Annoni, Anthony Moureau, Carlo Alberto Volta, Federico Franchi, Savino Spadaro

Introduction: In critically ill patients, individualised strategies for red blood cell transfusion (RBCT) are lacking. The objective of this study is to demonstrate the potential advantages of employing an individualised transfusion strategy compared with a restrictive approach, in unselected intensive care unit (ICU) patients.

Methods: This will be a randomised, multicentre, international trial. Two open-label parallel groups will be compared with an allocation ratio of 1:1. The trial is designed to investigate the superiority of the individualised intervention group compared with the standard intervention group. The study will be performed in three mixed, academic ICUs located in two different countries. In the individualised group, prescription of RCBT is restricted to patients who present haemoglobin (Hb) ≤9.0 g/dL and oxygen extraction ratio (O2ER) ≥ 30%, for a minimum Hb value of ≤6.0 g/dL. In the control group, prescription of RBCT is guided by thresholds proposed by recent guidelines, regardless of O2ER values.

Ethics and dissemination: This trial is approved by the Comitato Etico Area Vasta Centro della Regione Emilia-Romagna (protocol number 350/2023/Sper/AOUFe/PRBCT, date of approval 18/05/2023) and ethic boards at all participating sites. Our results will be published and shared with relevant organisations and healthcare professionals.

Trial registration number: Clinicaltrials.gov NCT06102590.

导言:在重症患者中,缺乏个性化的红细胞输注(RBCT)策略。本研究的目的是在未经选择的重症监护病房(ICU)患者中,证明采用个体化输血策略与限制性输血策略相比的潜在优势:方法:这将是一项随机、多中心的国际试验。方法:这将是一项随机、多中心、国际性试验,将对两个开放标签平行组进行比较,分配比例为 1:1。试验旨在研究个性化干预组与标准干预组相比的优越性。研究将在两个不同国家的三家混合型学术重症监护病房进行。在个体化干预组中,RCBT 的处方仅限于血红蛋白(Hb)≤9.0 g/dL 和氧萃取率(O2ER)≥30% 的患者,最低 Hb 值为≤6.0 g/dL。在对照组中,RBCT 的处方以近期指南提出的阈值为指导,与 O2ER 值无关:本试验已获得艾米利亚-罗马涅大区Comitato Etico Area Vasta Centro(协议编号350/2023/Sper/AOUFe/PRBCT,批准日期2023年5月18日)和所有参与研究机构的伦理委员会的批准。我们的研究结果将公布于众,并与相关机构和医护人员分享:试验注册号:Clinicaltrials.gov NCT06102590。
{"title":"Oxygen extraction-guided transfusion strategy in critically ill patients: study protocol for a randomised, open-labelled, controlled trial.","authors":"Alberto Fogagnolo, Danila Azzolina, Fabio Silvio Taccone, Emma Pedarzani, Gianluca Pasa, Daniele Marianello, Giorgia Valpiani, Chiara Marchesini, Filippo Annoni, Anthony Moureau, Carlo Alberto Volta, Federico Franchi, Savino Spadaro","doi":"10.1136/bmjopen-2024-089910","DOIUrl":"https://doi.org/10.1136/bmjopen-2024-089910","url":null,"abstract":"<p><strong>Introduction: </strong>In critically ill patients, individualised strategies for red blood cell transfusion (RBCT) are lacking. The objective of this study is to demonstrate the potential advantages of employing an individualised transfusion strategy compared with a restrictive approach, in unselected intensive care unit (ICU) patients.</p><p><strong>Methods: </strong>This will be a randomised, multicentre, international trial. Two open-label parallel groups will be compared with an allocation ratio of 1:1. The trial is designed to investigate the superiority of the individualised intervention group compared with the standard intervention group. The study will be performed in three mixed, academic ICUs located in two different countries. In the individualised group, prescription of RCBT is restricted to patients who present haemoglobin (Hb) ≤9.0 g/dL and oxygen extraction ratio (O<sub>2</sub>ER) ≥ 30%, for a minimum Hb value of ≤6.0 g/dL. In the control group, prescription of RBCT is guided by thresholds proposed by recent guidelines, regardless of O<sub>2</sub>ER values.</p><p><strong>Ethics and dissemination: </strong>This trial is approved by the Comitato Etico Area Vasta Centro della Regione Emilia-Romagna (protocol number 350/2023/Sper/AOUFe/PRBCT, date of approval 18/05/2023) and ethic boards at all participating sites. Our results will be published and shared with relevant organisations and healthcare professionals.</p><p><strong>Trial registration number: </strong>Clinicaltrials.gov NCT06102590.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142614842","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Research and development investment of Chinese chemical pharmaceutical companies under the national pooled procurement: a retrospective panel data analysis, 2013-2022. 国家集采下中国化学制药企业的研发投入:2013-2022 年回顾性面板数据分析。
IF 2.4 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-12 DOI: 10.1136/bmjopen-2023-081503
Qianrun Lei, Qiyou Wu, Zhitao Wang, Jing Sun, Yuanli Liu

Objective: To generate evidence about changes in the research and development (R&D) investment of Chinese chemical pharmaceutical companies before and after the implementation of the national pooled procurement, to respond to the concerns that significant price reductions might negatively affect R&D investment, and to facilitate the evidence-based decision-making for improvement of the national pooled procurement.

Methods: This retrospective study employed the fixed-effects models with robust SEs to analyse the changes in R&D investment intensities of 76 A-share listed Chinese chemical pharmaceutical companies before and after the procurement implementation in 2019. The analyses were based on a panel data set between 2013 and 2022. Subgroup analyses were conducted to account for the heterogeneity of the target companies. The bootstrap hypothesis test method was employed to assess potential variations across the different subgroups.

Results: Following the procurement implementation, the R&D investment intensity (RDI) of the target companies increased by 1.9% (p<0.05) compared with the RDI before the procurement implementation. Successful bidders exhibited a higher RDI of 2.2% (p<0.01) compared with that of the other suppliers. The RDI of companies engaged in traditional Chinese medicine (TCM) production was found to be 2.4% lower (p<0.01) than that of companies not involved in TCM production. Similarly, the companies engaged in the production of active pharmaceutical ingredients (APIs) had a 1.6% lower (p<0.01) RDI than those not involved in API production.

Conclusions: This study found that the enthusiasm of Chinese chemical medicines companies towards investing in R&D following the medicines regulatory reforms was not suppressed when the pilot pooled procurement was expanded and continued. The overall level of RDI following the pilot was higher than that before the pilot during the entire observation period. The enhanced investment in R&D has been a distinctive feature of Chinese chemical pharmaceutical companies that position themselves with more substantial market competitiveness.

目标:获取国家集中采购实施前后中国化学制药企业研发投入变化的证据,以回应对大幅降价可能对研发投入产生负面影响的担忧,并为改进国家集中采购提供循证决策依据:本回顾性研究采用固定效应模型和稳健SE,分析了2019年采购实施前后76家A股中国化学制药上市公司研发投入强度的变化。分析基于 2013 年至 2022 年的面板数据集。考虑到目标公司的异质性,进行了分组分析。采用自举假设检验法评估不同分组间的潜在差异:结果:采购实施后,目标企业的研发投资强度(RDI)提高了 1.9%(pConclusions):本研究发现,药品监管改革后,中国化学药企业的研发投资热情并没有因为集中采购试点的扩大和延续而受到抑制。在整个观察期内,试点后的研发投入总体水平高于试点前。加强研发投入是中国化学制药企业的一个显著特点,使其具有更强的市场竞争力。
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引用次数: 0
Maintenance immunosuppressive therapy in liver transplantation: results from CESIT study, an Italian retrospective cohort study. 肝移植中的维持性免疫抑制疗法:意大利回顾性队列研究 CESIT 的结果。
IF 2.4 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-12 DOI: 10.1136/bmjopen-2024-087373
Arianna Bellini, Marco Finocchietti, Alessandro Cesare Rosa, Lucia Masiero, Silvia Trapani, Massimo Cardillo, Marco Massari, Stefania Spila Alegiani, Silvia Pierobon, Eliana Ferroni, Martina Zanforlini, Olivia Leoni, Stefano Ledda, Donatella Garau, Marina Davoli, Antonio Addis, Valeria Belleudi

Objectives: To investigate the use of maintenance immunosuppressive treatments following liver transplantation and to compare their risk-benefit profiles in clinical practice.

Design: Retrospective multicentrer cohort study.

Setting: Four Italian regions (Lombardy, Veneto, Lazio, Sardinia).

Methods: Data were integrated from the national transplant information system and administrative claims data from four Italian regions. All adults who underwent incident liver transplantation between 2009 and 2019 were identified and categorised into two groups: cirrhosis or hepatocellular carcinoma (HCC). The trend of immunosuppressive treatment over years was analysed, and their effectiveness/safety profiles were compared using multivariate Cox models (HR; 95% CI).

Main outcome measures: Mortality, transplant reject/graft failure, incidence of severe infections, cancer, diabetes, major adverse cardiovascular events and lipid-modifying agents use.

Results: The study comprised 750 subjects in the cirrhosis cohort and 1159 in the HCC cohort. Over the study years, there was a decline in the use of cyclosporine-CsA, while combination therapy involving tacrolimus with other drugs increased compared with monotherapy. Overall, tacrolimus monotherapy use was slightly over 40% in both groups, followed by tacrolimus+mycophenolate (39.5%-cirrhosis; 30.6%-HCC) and tacrolimus+molecular target of rapamycin inhibitors (mTORi) (8.5%-cirrhosis; 13.3%-HCC). No significant differences emerged in risk-benefit profile of different tacrolimus-based therapies, except for a higher risk of mortality in cirrhosis subjects under tacrolimus monotherapy compared with tacrolimus+mycophenolate (HR: 2.07; 1.17 to 3.65).

Conclusions: The study highlights a shift over time in postliver transplant therapeutic patterns, favouring the use of tacrolimus in combination with mycophenolate or mTORi, rather than monotherapy. Moreover, a potential association between tacrolimus monotherapy and increased mortality in the cirrhosis cohort was identified. Further research is warranted to investigate these findings more deeply and to optimise treatment strategies for liver transplant recipients.

目的调查肝移植术后维持性免疫抑制治疗的使用情况,并比较其在临床实践中的风险-效益情况:设计:回顾性多中心队列研究:地点:意大利四个大区(伦巴第大区、威尼托大区、拉齐奥大区、撒丁岛大区):方法:从国家移植信息系统和意大利四个大区的行政报销数据中整合数据。2009年至2019年期间,所有接受过肝移植手术的成年人都被识别出来,并被分为两组:肝硬化或肝细胞癌(HCC)。使用多变量考克斯模型(HR;95% CI)分析了多年来免疫抑制治疗的趋势,并对其有效性/安全性进行了比较:主要结果指标:死亡率、移植排斥/移植物失败、严重感染发生率、癌症、糖尿病、主要不良心血管事件和调脂药物的使用:研究包括肝硬化队列中的 750 名受试者和 HCC 队列中的 1159 名受试者。在研究期间,环孢素-CsA的使用率有所下降,而他克莫司与其他药物的联合疗法与单一疗法相比有所增加。总体而言,两组中使用他克莫司单药治疗的比例均略高于 40%,其次是他克莫司+霉酚酸酯(39.5%-肝硬化;30.6%-肝癌)和他克莫司+雷帕霉素分子靶点抑制剂(mTORi)(8.5%-肝硬化;13.3%-肝癌)。基于他克莫司的不同疗法在风险-效益方面无明显差异,只是与他克莫司+霉酚酸盐相比,接受他克莫司单药治疗的肝硬化患者的死亡风险更高(HR:2.07;1.17-3.65):该研究强调了肝移植后治疗模式随着时间的推移而发生的变化,即倾向于他克莫司与霉酚酸酯或mTORi联合使用,而非单药治疗。此外,研究还发现他克莫司单药治疗与肝硬化队列中死亡率升高之间存在潜在关联。为了更深入地研究这些发现并优化肝移植受者的治疗策略,有必要开展进一步的研究。
{"title":"Maintenance immunosuppressive therapy in liver transplantation: results from CESIT study, an Italian retrospective cohort study.","authors":"Arianna Bellini, Marco Finocchietti, Alessandro Cesare Rosa, Lucia Masiero, Silvia Trapani, Massimo Cardillo, Marco Massari, Stefania Spila Alegiani, Silvia Pierobon, Eliana Ferroni, Martina Zanforlini, Olivia Leoni, Stefano Ledda, Donatella Garau, Marina Davoli, Antonio Addis, Valeria Belleudi","doi":"10.1136/bmjopen-2024-087373","DOIUrl":"https://doi.org/10.1136/bmjopen-2024-087373","url":null,"abstract":"<p><strong>Objectives: </strong>To investigate the use of maintenance immunosuppressive treatments following liver transplantation and to compare their risk-benefit profiles in clinical practice.</p><p><strong>Design: </strong>Retrospective multicentrer cohort study.</p><p><strong>Setting: </strong>Four Italian regions (Lombardy, Veneto, Lazio, Sardinia).</p><p><strong>Methods: </strong>Data were integrated from the national transplant information system and administrative claims data from four Italian regions. All adults who underwent incident liver transplantation between 2009 and 2019 were identified and categorised into two groups: cirrhosis or hepatocellular carcinoma (HCC). The trend of immunosuppressive treatment over years was analysed, and their effectiveness/safety profiles were compared using multivariate Cox models (HR; 95% CI).</p><p><strong>Main outcome measures: </strong>Mortality, transplant reject/graft failure, incidence of severe infections, cancer, diabetes, major adverse cardiovascular events and lipid-modifying agents use.</p><p><strong>Results: </strong>The study comprised 750 subjects in the cirrhosis cohort and 1159 in the HCC cohort. Over the study years, there was a decline in the use of cyclosporine-CsA, while combination therapy involving tacrolimus with other drugs increased compared with monotherapy. Overall, tacrolimus monotherapy use was slightly over 40% in both groups, followed by tacrolimus+mycophenolate (39.5%-cirrhosis; 30.6%-HCC) and tacrolimus+molecular target of rapamycin inhibitors (mTORi) (8.5%-cirrhosis; 13.3%-HCC). No significant differences emerged in risk-benefit profile of different tacrolimus-based therapies, except for a higher risk of mortality in cirrhosis subjects under tacrolimus monotherapy compared with tacrolimus+mycophenolate (HR: 2.07; 1.17 to 3.65).</p><p><strong>Conclusions: </strong>The study highlights a shift over time in postliver transplant therapeutic patterns, favouring the use of tacrolimus in combination with mycophenolate or mTORi, rather than monotherapy. Moreover, a potential association between tacrolimus monotherapy and increased mortality in the cirrhosis cohort was identified. Further research is warranted to investigate these findings more deeply and to optimise treatment strategies for liver transplant recipients.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142614761","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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