A Before and After Study of the Effect of Ceasing to Give Antibiotic Prophylaxis

停止给予抗生素预防效果的前后研究

• 批准号: 8423913
• 负责人: MARTIN H THORNHILL
• 金额: $ 10.8万
• 依托单位: UNIVERSITY OF SHEFFIELD
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-18 至 2017-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8423913
• 关键词: Admission activity; Adverse reactions; American Heart Association; Antibiotic Prophylaxis; Antibiotic Resistance; Antibiotics; Bacteremia; Blood Circulation; Cardiovascular system; Categories; Cessation of life; Clinical; Clinical Trials; Data; Death Rate; Dental; Dental Care; Development; Disease; Eating; Guidelines; Heart Valve Prosthesis; Heart Valves; Hospitals; Incidence; Infection; Infective endocarditis; Length of Stay; Link; Methods; Oral; Oral cavity; Organism; Patients; Placebos; Prevention; Public Health; Randomized Controlled Trials; Recommendation; Recording of previous events; Risk; Solid; Toothbrushing; United Kingdom; United States National Institutes of Health; clinical practice; evidence base; falls; high risk; killings; mortality; prevent; public health relevance; standard of care; statistics; toothbrush

DESCRIPTION (provided by applicant): Infective endocarditis (IE) is an infection of the heart valves, most often caused by circulating bacteria (bacteremia). There are ~27,000 cases a year in the USA and it is associated with high mortality (~30% within the first year) and serious long-term complications. Oral bacteria are implicated in 35-45% of IE cases. It is well documented that bacteremia occur during eating, tooth-brushing and invasive dental procedures. Because of this, the American Heart Association (AHA) guideline committee recommends that patients at highest risk from developing IE should be given antibiotic prophylaxis (AP) before invasive dental procedures, with the aim of killing bacteria that enter the circulation. Most cardiovascular guidelines committees around the world recommend AP for these people. However, there has never been a clinical trial of AP and there is a lack of scientific evidence to support the practic of giving AP. In the UK, AP was the 'standard of care' until March 2008 when the National Institute for Health and Clinical Excellence (NICE) introduced new guidelines recommending the complete cessation of AP prescribing in the UK. Since then the 'standard of care' has been NOT to prescribe AP prior to dental procedures. Objectives: To determine the efficacy of AP in preventing IE by performing a before and after study comparing the incidence of IE when AP was the 'standard of care' in the UK (before March 2008) with the incidence of IE when the 'standard of care' was NOT to give AP (after March 2008). Specific Aims: To perform a before and after study of the impact of the recommendation in the UK to stop giving AP, prior to invasive dental procedures, on the incidence of IE. Methods: We will: (1) Analyze National Prescribing data to determine the level of AP prescribing prior to and in the 4 years after the introduction of the NICE guidelines. (2) Analyze national Hospital Episode Statistics (HES) data to determine the incidence of IE prior to and in the 4 years after the introduction of the NICE guidelines. (3) Analyze links between HES data and Office of National Statistics data to determine the incidence of IE related mortality, during the hospital stay to treat IE and within 90 days of hospital admission, before and after the introduction of the NICE guidelines. (5) In addition, we will do the following sub-analysis of the IE incidence and mortality data: (a) In orde to more directly assess the benefit of AP in preventing IE caused by oral bacteria, we will determine the incidence of IE and IE related mortality for those patients where the causal organism was recorded as being of oral origin. (b) To more directly evaluate the potential benefit of the current AHA guidelines, we will also determine the incidence of IE and IE related mortality in those patients with a pre-existing prosthetic heart valve or previous history of IE, and who therefore fall into the AHA 'High-Risk' category indicated to receive AP under the current AHA guidelines.

描述(申请人提供)：感染性心内膜炎(IE)是心脏瓣膜的感染，最常见的是由循环细菌(菌血症)引起的。在美国每年约有27,000例，且与高死亡率(第一年内约30%)和严重的长期并发症有关。35-45%的IE病例涉及口腔细菌。众所周知，菌血症发生在进食、刷牙和侵入性牙科手术过程中。正因为如此，美国心脏协会(AHA)指南委员会建议，患有IE风险最高的患者在进行侵入性牙科手术之前应该给予抗生素预防(AP)，目的是杀死进入循环的细菌。大多数心血管疾病 世界各地的指南委员会向这些人推荐AP。然而，目前还没有关于AP的临床试验，也缺乏科学证据来支持给予AP的实践。在英国，AP一直是“护理的标准”，直到2008年3月，国家健康与临床卓越研究所(NICE)推出了新的指南，建议在英国完全停止开AP处方。从那时起，“护理的标准”就是在牙科手术前不开AP处方。目的：通过比较在英国以急性胰腺炎为“护理标准”时(2008年3月以前)和非“护理标准”时(2008年3月以后)IE的发病率，确定急性胰腺炎预防IE的效果。具体目标：对英国建议在有创牙科手术前停止给予AP对IE发病率的影响进行一项前后研究。方法：(1)分析NICE指南出台前和实施后4年内的AP处方水平。(2)分析国家医院流行病学统计(HES)数据，以确定NICE指南出台前和实施后4年内IE的发病率。(3)分析HES数据和国家统计局数据之间的联系，以确定IE相关死亡率的发生率、住院治疗IE期间和90内 住院天数，NICE指南出台前后。(5)此外，我们将对IE的发病率和死亡率数据进行以下细分分析：(A)为了更直接地评估AP在预防由口腔细菌引起的IE方面的益处，我们将确定那些病原体记录为口腔来源的患者的IE发病率和IE相关死亡率。(B)为了更直接地评估现行AHA指南的潜在益处，我们还将确定那些预先存在人工心脏瓣膜或有IE病史的患者的IE和IE相关死亡率，这些患者因此属于AHA‘高危’类别，根据当前AHA指南显示他们接受了AP治疗。