• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法,用中文像聊天一样搜索,搜遍4000万医学文献。AI智能推荐,让科研检索更轻松。

立即免费搜索

文件翻译

保留排版,准确专业,支持PDF/Word/PPT等文件格式,支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述,25分钟生成高质量综述,智能提取关键信息,辅助科研写作。

立即免费体验

大数据:创建并扩展一项为期25年的临床试验及观察性数据资产的方案,以填补澳大利亚原住民和非原住民儿童中耳炎与听力损失方面的关键知识空白。

BIGDATA: A Protocol to Create and Extend a 25-Year Clinical Trial and Observational Data Asset to Address Key Knowledge Gaps in Otitis Media and Hearing Loss in Australian Aboriginal and Non-Aboriginal Children.

作者信息

Beissbarth Jemima, Smith-Vaughan Heidi C, Cheng Allen C, Morris Peter S, Leach Amanda J

机构信息

Menzies School of Health Research, Charles Darwin University, Darwin, NT, Australia.

School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.

出版信息

Front Pediatr. 2022 Apr 14;10:804373. doi: 10.3389/fped.2022.804373. eCollection 2022.

DOI:10.3389/fped.2022.804373
PMID:35498792
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9047683/
Abstract

INTRODUCTION

Otitis media (OM) is a common childhood illness, often resolving without intervention and acute and long-term complications are rare. However, Australian Aboriginal and Torres Strait Islander infants and children experience a high burden of OM and are at high risk of complications (tympanic membrane perforation and chronic infections). Bacterial OM is commonly associated with , non-typeable , and . BIGDATA is a data asset combining over 25 years of microbiology and OM surveillance research from the Ear Health Research Program at Menzies School of Health Research (Northern Territory, Australia), including 11 randomized controlled trials, four cohort studies, eight surveys in over 30 remote communities (including data from Western Australia), and five surveys of urban childcare centers including Aboriginal and Torres Strait Islander and non-Indigenous children. Outcome measures include clinical examinations (focusing on OM), antibiotic prescriptions, pneumococcal vaccination, modifiable risk factors such as smoking and household crowding, and nasopharyngeal and ear discharge microbiology including antimicrobial resistance testing.

METHODS AND ANALYSIS

The initial series of projects are planned to address the following key knowledge gaps: (i) otitis media prevalence and severity over pre pneumococcal conjugate vaccines (PCVs) and three eras of increasing PCV valency; (ii) impact of increasing valency PCVs on nasopharyngeal carriage dynamics of pneumococcal serotypes, and antimicrobial resistance; (iii) impact of increasing valency PCVs on nasopharyngeal carriage dynamics and antimicrobial resistance of other otopathogens; and (iv) serotype specific differences between children with acute OM and OM with effusion or without OM. These data will be utilized to identify research gaps, providing evidence-based prioritization for ongoing research.

ETHICS AND DISSEMINATION

Data asset creation and priority analyses were approved by the Human Research Ethics Committee of Northern Territory Department of Health and Menzies School of Health Research (EC00153, 18-3281), the Child and Adolescent Health Service Human Research Ethics Committee and Western Australian Aboriginal Health Ethics Committee. Dissemination will be through peer review publication and conference presentations.

摘要

引言

中耳炎(OM)是一种常见的儿童疾病,通常无需干预即可痊愈,急性和长期并发症很少见。然而,澳大利亚原住民和托雷斯海峡岛民的婴幼儿中耳炎负担较重,且有较高的并发症风险(鼓膜穿孔和慢性感染)。细菌性中耳炎通常与、不可分型以及有关。BIGDATA是一项数据资产,结合了来自澳大利亚北部地区梅齐斯健康研究学院耳部健康研究项目25多年的微生物学和中耳炎监测研究,包括11项随机对照试验、4项队列研究、对30多个偏远社区的8项调查(包括来自西澳大利亚的数据)以及对城市儿童保育中心的5项调查,其中包括原住民和托雷斯海峡岛民儿童以及非原住民儿童。结果指标包括临床检查(重点是中耳炎)、抗生素处方、肺炎球菌疫苗接种、可改变的风险因素如吸烟和家庭拥挤情况,以及鼻咽部和耳部分泌物微生物学,包括抗菌药物耐药性检测。

方法与分析

最初的一系列项目计划解决以下关键知识空白:(i)在肺炎球菌结合疫苗(PCV)接种前以及PCV价数不断增加的三个时期的中耳炎患病率和严重程度;(ii)PCV价数增加对肺炎球菌血清型鼻咽部携带动态以及抗菌药物耐药性的影响;(iii)PCV价数增加对其他耳病原体鼻咽部携带动态和抗菌药物耐药性的影响;以及(iv)急性中耳炎患儿与积液性中耳炎或无中耳炎患儿之间的血清型特异性差异。这些数据将用于识别研究空白,为正在进行的研究提供基于证据的优先级排序。

伦理与传播

数据资产创建和优先级分析已获得北领地卫生部人类研究伦理委员会和梅齐斯健康研究学院(EC00153,18 - 3281)、儿童和青少年健康服务人类研究伦理委员会以及西澳大利亚原住民健康伦理委员会的批准。传播将通过同行评审发表和会议报告进行。

相似文献

1
BIGDATA: A Protocol to Create and Extend a 25-Year Clinical Trial and Observational Data Asset to Address Key Knowledge Gaps in Otitis Media and Hearing Loss in Australian Aboriginal and Non-Aboriginal Children.大数据:创建并扩展一项为期25年的临床试验及观察性数据资产的方案,以填补澳大利亚原住民和非原住民儿童中耳炎与听力损失方面的关键知识空白。
Front Pediatr. 2022 Apr 14;10:804373. doi: 10.3389/fped.2022.804373. eCollection 2022.
2
General health, otitis media, nasopharyngeal carriage and middle ear microbiology in Northern Territory Aboriginal children vaccinated during consecutive periods of 10-valent or 13-valent pneumococcal conjugate vaccines.在连续接种10价或13价肺炎球菌结合疫苗期间,北领地原住民儿童的总体健康状况、中耳炎、鼻咽部携带情况及中耳微生物学
Int J Pediatr Otorhinolaryngol. 2016 Jul;86:224-32. doi: 10.1016/j.ijporl.2016.05.011. Epub 2016 May 11.
3
Pneumococcal conjugate vaccines PREVenar13 and SynflorIX in sequence or alone in high-risk Indigenous infants (PREV-IX_COMBO): protocol of a randomised controlled trial.肺炎球菌结合疫苗PREVenar13和SynflorIX序贯或单独用于高危原住民婴儿(PREV-IX_COMBO):一项随机对照试验方案
BMJ Open. 2015 Jan 16;5(1):e007247. doi: 10.1136/bmjopen-2014-007247.
4
Vaccine preventable diseases and vaccination coverage in Aboriginal and Torres Strait Islander people, Australia 2006-2010.2006 - 2010年澳大利亚原住民和托雷斯海峡岛民中疫苗可预防疾病及疫苗接种覆盖率
Commun Dis Intell Q Rep. 2013 Dec 31;37 Suppl:S1-95.
5
Otitis media at 6-monthly assessments of Australian First Nations children between ages 12-36 months: Findings from two randomised controlled trials of combined pneumococcal conjugate vaccines.对12至36个月大的澳大利亚原住民儿童进行每6个月一次评估时的中耳炎情况:两项肺炎球菌结合疫苗联合随机对照试验的结果
Int J Pediatr Otorhinolaryngol. 2023 Dec;175:111776. doi: 10.1016/j.ijporl.2023.111776. Epub 2023 Nov 6.
6
Ear microbiota and middle ear disease: a longitudinal pilot study of Aboriginal children in a remote south Australian setting.耳微生物群与中耳疾病:南澳大利亚偏远地区原住民儿童的纵向试点研究。
BMC Microbiol. 2022 Jan 13;22(1):24. doi: 10.1186/s12866-022-02436-x.
7
Nasopharyngeal carriage of otitis media pathogens in infants receiving 10-valent non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10), 13-valent pneumococcal conjugate vaccine (PCV13) or a mixed primary schedule of both vaccines: A randomised controlled trial.婴幼儿接种 10 价无荚膜流感嗜血杆菌蛋白 D 结合疫苗(PHiD-CV10)、13 价肺炎球菌结合疫苗(PCV13)或两者混合基础免疫程序后鼻咽部携带中耳炎病原菌的情况:一项随机对照试验。
Vaccine. 2021 Apr 15;39(16):2264-2273. doi: 10.1016/j.vaccine.2021.03.032. Epub 2021 Mar 23.
8
Association between early bacterial carriage and otitis media in Aboriginal and non-Aboriginal children in a semi-arid area of Western Australia: a cohort study.半干旱地区澳式原住民与非原住民儿童中早期细菌定植与中耳炎的相关性:队列研究。
BMC Infect Dis. 2012 Dec 21;12:366. doi: 10.1186/1471-2334-12-366.
9
Reduced middle ear infection with non-typeable Haemophilus influenzae, but not Streptococcus pneumoniae, after transition to 10-valent pneumococcal non-typeable H. influenzae protein D conjugate vaccine.转换为10价肺炎球菌结合疫苗后,非分型流感嗜血杆菌引起的中耳感染减少,但肺炎链球菌引起的中耳感染未减少。
BMC Pediatr. 2015 Oct 19;15:162. doi: 10.1186/s12887-015-0483-8.
10
Predominant Bacterial and Viral Otopathogens Identified Within the Respiratory Tract and Middle Ear of Urban Australian Children Experiencing Otitis Media Are Diversely Distributed.在澳大利亚城市儿童的呼吸道和中耳中发现的主要细菌和病毒耳病原体分布多样。
Front Cell Infect Microbiol. 2022 Mar 11;12:775535. doi: 10.3389/fcimb.2022.775535. eCollection 2022.

本文引用的文献

1
Phase 1 trial of a 20-valent pneumococcal conjugate vaccine in healthy adults.20 价肺炎球菌结合疫苗在健康成年人中的 1 期临床试验。
Vaccine. 2019 Sep 30;37(42):6201-6207. doi: 10.1016/j.vaccine.2019.08.048. Epub 2019 Sep 5.
2
Consolidated criteria for strengthening reporting of health research involving indigenous peoples: the CONSIDER statement.强化原住民健康研究报告的统一标准:CONSIDER 声明。
BMC Med Res Methodol. 2019 Aug 9;19(1):173. doi: 10.1186/s12874-019-0815-8.
3
Birth outcomes in Aboriginal mother-infant pairs from the Northern Territory, Australia, who received 23-valent polysaccharide pneumococcal vaccination during pregnancy, 2006-2011: The PneuMum randomised controlled trial.2006 - 2011年澳大利亚北领地接受孕期23价多糖肺炎球菌疫苗接种的原住民母婴对的出生结局:PneuMum随机对照试验
Aust N Z J Obstet Gynaecol. 2020 Feb;60(1):82-87. doi: 10.1111/ajo.13002. Epub 2019 Jun 14.
4
Use of the 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) in an Australian Indigenous paediatric population does not alter the prevalence of nontypeable Haemophilus influenzae without the protein D gene.使用 10 价肺炎球菌结合疫苗(PHiD-CV10)在澳大利亚原住民儿科人群中使用不会改变无蛋白 D 基因的非典型流感嗜血杆菌的流行率。
Vaccine. 2019 Jul 9;37(30):4089-4093. doi: 10.1016/j.vaccine.2019.05.079. Epub 2019 Jun 1.
5
Impact of the 23-valent pneumococcal polysaccharide vaccination in pregnancy against infant acute lower respiratory infections in the Northern Territory of Australia.23价肺炎球菌多糖疫苗在澳大利亚北领地孕期接种对婴儿急性下呼吸道感染的影响。
Pneumonia (Nathan). 2018 Dec 25;10:13. doi: 10.1186/s41479-018-0057-2. eCollection 2018.
6
A comparison of flocked nylon swabs and non-flocked rayon swabs for detection of respiratory bacteria in nasopharyngeal carriage in Australian Indigenous children.澳大利亚土著儿童鼻咽携带呼吸道细菌中,植绒尼龙拭子与非植绒人造纤维拭子检测的比较。
J Microbiol Methods. 2019 Feb;157:47-49. doi: 10.1016/j.mimet.2018.12.013. Epub 2018 Dec 19.
7
Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants.15 价肺炎球菌结合疫苗(PCV15)在健康婴儿中的安全性和免疫原性。
Vaccine. 2018 Oct 29;36(45):6883-6891. doi: 10.1016/j.vaccine.2018.02.113. Epub 2018 Sep 21.
8
Estimates of the global, regional, and national morbidity, mortality, and aetiologies of lower respiratory infections in 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016.2016 年全球 195 个国家/地区下呼吸道感染的发病率、死亡率和病因的全球、区域和国家估计值:2016 年全球疾病负担研究的系统分析。
Lancet Infect Dis. 2018 Nov;18(11):1191-1210. doi: 10.1016/S1473-3099(18)30310-4. Epub 2018 Sep 19.
9
Immunogenicity and safety of 11- and 12-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccines (11vPHiD-CV, 12vPHiD-CV) in infants: Results from a phase II, randomised, multicentre study.11 价和 12 价肺炎球菌/无乳链球菌蛋白 D 结合疫苗(11vPHiD-CV、12vPHiD-CV)在婴儿中的免疫原性和安全性:一项 II 期、随机、多中心研究的结果。
Vaccine. 2019 Jan 3;37(1):176-186. doi: 10.1016/j.vaccine.2018.07.023. Epub 2018 Jul 24.
10
Bacteria and viruses in the nasopharynx immediately prior to onset of acute lower respiratory infections in Indigenous Australian children.鼻咽部细菌和病毒与澳大利亚土著儿童急性下呼吸道感染的关系。
Eur J Clin Microbiol Infect Dis. 2018 Sep;37(9):1785-1794. doi: 10.1007/s10096-018-3314-7. Epub 2018 Jun 29.