Francis Jill J, Duncan Eilidh M, Prior Maria E, Maclennan Graeme S, Dombrowski Stephan, Bellingan Geoff U, Campbell Marion K, Eccles Martin P, Rose Louise, Rowan Kathryn M, Shulman Rob, Peter R Wilson A, Cuthbertson Brian H
Health Psychology Group, University of Aberdeen, Aberdeen, UK.
Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
Health Technol Assess. 2014 Apr;18(25):1-170. doi: 10.3310/hta18250.
Hospital-acquired infections (HAIs) are a major cause of morbidity and mortality. Critically ill patients in intensive care units (ICUs) are particularly susceptible to these infections. One intervention that has gained much attention in reducing HAIs is selective decontamination of the digestive tract (SDD). SDD involves the application of topical non-absorbable antibiotics to the oropharynx and stomach and a short course of intravenous (i.v.) antibiotics. SDD may reduce infections and improve mortality, but has not been widely adopted in the UK or internationally. Hence, there is a need to identify the reasons for low uptake and whether or not further clinical research is needed before wider implementation would be considered appropriate.
The project objectives were to (1) identify and describe the SDD intervention, (2) identify views about the evidence base, (3) identify acceptability of further research and (4) identify feasibility of further randomised controlled trials (RCTs).
A four-stage approach involving (1) case studies of two ICUs in which SDD is delivered including observations, interviews and documentary analysis, (2) a three-round Delphi study for in-depth investigation of clinicians' views, including semi-structured interviews and two iterations of questionnaires with structured feedback, (3) a nationwide online survey of consultants in intensive care medicine and clinical microbiology and (4) semistructured interviews with international clinical triallists to identify the feasibility of further research.
Case studies were set in two UK ICUs. Other stages of this research were conducted by telephone and online with NHS staff working in ICUs.
(1) Staff involved in SDD adoption or delivery in two UK ICUs, (2) ICU experts (intensive care consultants, clinical microbiologists, hospital pharmacists and ICU clinical leads), (3) all intensive care consultants and clinical microbiologists in the UK with responsibility for patients in ICUs were invited and (4) international triallists, selected from their research profiles in intensive care, clinical trials and/or implementation trials.
SDD involves the application of topical non-absorbable antibiotics to the oropharynx and stomach and a short course of i.v. antibiotics.
Levels of support for, or opposition to, SDD in UK ICUs; views about the SDD evidence base and about barriers to implementation; and feasibility of further SDD research (e.g. likely participation rates).
(1) The two case studies identified complexity in the interplay of clinical and behavioural components of SDD, involving multiple staff. However, from the perspective of individual staff, delivery of SDD was regarded as simple and straightforward. (2) The Delphi study (n = 42) identified (a) specific barriers to SDD implementation, (b) uncertainty about the evidence base and (c) bimodal distributions for key variables, e.g. support for, or opposition to, SDD. (3) The national survey (n = 468) identified uncertainty about the effect of SDD on antimicrobial resistance, infection rates, mortality and cost-effectiveness. Most participants would participate in further SDD research. (4) The triallist interviews (n = 10) focused largely on the substantial challenges of conducting a large, multinational clinical effectiveness trial.
There was considerable uncertainty about possible benefits and harms of SDD. Further large-scale clinical effectiveness trials of SDD in ICUs may be required to address these uncertainties, especially relating to antimicrobial resistance. There was a general willingness to participate in a future effectiveness RCT of SDD. However, support was not unanimous. Future research should address the barriers to acceptance and participation in any trial. There was some, but a low level of, interest in adoption of SDD, or studies to encourage implementation of SDD into practice.
This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 25. See the NIHR Journals Library website for further project information.
医院获得性感染（HAIs）是发病和死亡的主要原因。重症监护病房（ICU）中的重症患者尤其易受这些感染的影响。在减少医院获得性感染方面备受关注的一项干预措施是消化道选择性去污（SDD）。SDD包括在口咽部和胃部局部应用不可吸收的抗生素以及短期静脉注射抗生素。SDD可能会减少感染并提高生存率，但在英国或国际上尚未得到广泛应用。因此，有必要确定采用率低的原因以及在考虑更广泛实施之前是否需要进一步的临床研究。
该项目的目标是：（1）识别并描述SDD干预措施；（2）确定对证据基础的看法；（3）确定进一步研究的可接受性；（4）确定进一步进行随机对照试验（RCTs）的可行性。
采用四阶段方法，包括：（1）对实施SDD的两个ICU进行案例研究，包括观察、访谈和文献分析；（2）三轮德尔菲研究，深入调查临床医生的观点，包括半结构化访谈和两轮带有结构化反馈的问卷调查；（3）对重症监护医学和临床微生物学顾问进行全国性在线调查；（4）与国际临床研究人员进行半结构化访谈，以确定进一步研究的可行性。
案例研究在英国的两个ICU中进行。本研究的其他阶段通过电话和在线方式与在ICU工作的NHS工作人员进行。
（1）英国两个ICU中参与采用或实施SDD的工作人员；（2）ICU专家（重症监护顾问、临床微生物学家、医院药剂师和ICU临床负责人）；（3）邀请了英国所有负责ICU患者的重症监护顾问和临床微生物学家；（4）从他们在重症监护、临床试验和/或实施试验方面的研究资料中挑选出的国际研究人员。
SDD包括在口咽部和胃部局部应用不可吸收的抗生素以及短期静脉注射抗生素。
英国ICU中对SDD的支持或反对程度；对SDD证据基础和实施障碍的看法；以及进一步进行SDD研究的可行性（如可能的参与率）。
（1）两个案例研究确定了SDD临床和行为成分相互作用的复杂性，涉及多名工作人员。然而，从个体工作人员的角度来看，实施SDD被认为简单直接。（2）德尔菲研究（n = 42）确定了：（a）SDD实施的具体障碍；（b）证据基础的不确定性；（c）关键变量的双峰分布，例如对SDD的支持或反对。（3）全国性调查（n = 468）确定了SDD对抗菌药物耐药性、感染率、死亡率和成本效益影响的不确定性。大多数参与者愿意参与进一步的SDD研究。（4）对研究人员的访谈（n = 10）主要集中在进行大规模、跨国临床疗效试验的重大挑战上。
关于SDD可能的益处和危害存在相当大的不确定性。可能需要在ICU中对SDD进行进一步的大规模临床疗效试验，以解决这些不确定性，特别是与抗菌药物耐药性相关的问题。人们普遍愿意参与未来SDD的疗效随机对照试验。然而，支持并非一致。未来的研究应解决接受和参与任何试验的障碍。对于采用SDD或鼓励将SDD应用于实践的研究，有一定但程度较低的兴趣。
该项目由英国国家卫生研究院卫生技术评估计划资助，将全文发表在《卫生技术评估》；第18卷，第25期。有关该项目的更多信息，请访问英国国家卫生研究院期刊图书馆网站。
