Routine molecular point-of-care testing for respiratory viruses in adults presenting to hospital with acute respiratory illness (ResPOC): a pragmatic, open-label, randomised controlled trial.
Routine molecular point-of-care testing for respiratory viruses in adults presenting to hospital with acute respiratory illness (ResPOC): a pragmatic, open-label, randomised controlled trial.
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DOI：
10.1016/s2213-2600(17)30120-0
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发表时间：
2017-05
期刊：
影响因子：
--
通讯作者：
Clark TW
中科院分区：
文献类型：
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作者：
Brendish NJ;Malachira AK;Armstrong L;Houghton R;Aitken S;Nyimbili E;Ewings S;Lillie PJ;Clark TW
呼吸道病毒感染是成人住院的常见原因。通过减少不必要的抗生素使用、缩短住院时间、改进流感检测和治疗以及合理化隔离设施的使用，呼吸道病毒的快速护理点检测（POCT）可能会改善临床护理；然而，没有足够的证据支持其在标准临床护理中使用。我们的目的是评估常规POCT对包括抗生素使用在内的广泛临床结果的影响。在这项实用的、平行组、开放标签、随机对照试验中，我们招募了在两个冬季期间，在英国一家大型医院急诊部或急诊科就诊24小时内患有急性呼吸道疾病或发烧高于37.5°C（≤7天）或两者兼有的成年人（年龄≥18岁）。患者通过基于互联网的随机排列区块分配序列随机分配（1:1），接受呼吸道病毒分子POC检测或常规临床护理。主要结局是住院期间（长达30天）接受抗生素治疗的患者比例。次要结局包括抗生素持续时间、接受单剂量或短期抗生素治疗的患者比例、住院时间、抗病毒药物的使用、隔离设施的使用和安全性。通过修改治疗意向进行分析，排除拒绝干预或因违反协议而退出治疗的患者。本研究已在ISRCTN注册，注册号为90211642，并已完成。在2015年1月15日至2015年4月30日以及2015年10月1日至2016年4月30日期间，我们纳入了720例患者（362例分配到POCT， 358例分配到常规护理）。六名患者退出治疗或违反了治疗方案。POCT组360例患者中有301例（84%）接受抗生素治疗，而对照组354例患者中有294例（83%）接受抗生素治疗（差异为0.6%，95% CI为- 4.9 ~ 6.0;p= 0.84）。各组间抗生素的平均持续时间无差异（POCT组为7.2天[SD 5.1]，对照组为7.7天[4.9]；差异为- 0.4,95% CI为- 1.2 ~ 0.4;p= 0.32）。POCT组301例接受抗生素治疗的患者中有50例（17%）接受单剂量或短疗程抗生素治疗（<48 h），而对照组294例患者中有26例（9%）接受单剂量或短疗程抗生素治疗（差异7.8%,95% CI 2.5 ~ 13.1; p= 0.0047；需要检测的人数=13）。POCT组的平均住院时间（5.7天[SD 6.3]）短于对照组（6.8天[7.7]），差异为- 1.1,95% CI为- 2.2 ~ - 0.3,p= 0.0443。POCT组（57例患者中有52例[91%]）比对照组（37例患者中有24例[65%]；差异26.4%，95% CI为9.6 ~ 42.3;p= 0.0026；需要检测的人数=4）对流感阳性患者进行适当抗病毒治疗更为常见。我们发现两组之间的不良结局没有差异（POCT组360例患者中有77例[21%]vs对照组354例患者中有88例[25%]；- 3.5%,- 9.7至2.7;p= 0.29）。常规使用分子POCT治疗呼吸道病毒并没有减少使用抗生素治疗的患者比例。然而，主要结局指标未能捕捉到抗生素使用的差异，因为许多患者在POCT结果可用之前就开始使用抗生素。虽然POCT总体上与抗生素持续时间的减少无关，但与对照组相比，POCT组中接受单剂量或短疗程抗生素治疗的患者更多。POCT还与缩短住院时间、改善流感检测和抗病毒药物使用有关，并且似乎是安全的。南安普顿大学。
Respiratory virus infection is a common cause of hospitalisation in adults. Rapid point-of-care testing (POCT) for respiratory viruses might improve clinical care by reducing unnecessary antibiotic use, shortening length of hospital stay, improving influenza detection and treatment, and rationalising isolation facility use; however, insufficient evidence exists to support its use over standard clinical care. We aimed to assess the effect of routine POCT on a broad range of clinical outcomes including antibiotic use. In this pragmatic, parallel-group, open-label, randomised controlled trial, we enrolled adults (aged ≥18 years) within 24 h of presenting to the emergency department or acute medical unit of a large UK hospital with acute respiratory illness or fever higher than 37·5°C (≤7 days duration), or both, over two winter seasons. Patients were randomly assigned (1:1), via an internet-based allocation sequence with random permuted blocks, to have a molecular POC test for respiratory viruses or routine clinical care. The primary outcome was the proportion of patients who received antibiotics while hospitalised (up to 30 days). Secondary outcomes included duration of antibiotics, proportion of patients receiving single doses or brief courses of antibiotics, length of stay, antiviral use, isolation facility use, and safety. Analysis was by modified intention to treat, excluding patients who declined intervention or were withdrawn for protocol violations. This study is registered with ISRCTN, number 90211642, and has been completed. Between Jan 15, 2015, and April 30, 2015, and between Oct 1, 2015, and April 30, 2016, we enrolled 720 patients (362 assigned to POCT and 358 to routine care). Six patients withdrew or had protocol violations. 301 (84%) of 360 patients in the POCT group received antibiotics compared with 294 (83%) of 354 controls (difference 0·6%, 95% CI −4·9 to 6·0; p=0·84). Mean duration of antibiotics did not differ between groups (7·2 days [SD 5·1] in the POCT group vs 7·7 days [4·9] in the control group; difference −0·4, 95% CI −1·2 to 0·4; p=0·32). 50 (17%) of 301 patients treated with antibiotics in the POCT group received single doses or brief courses of antibiotics (<48 h) compared with 26 (9%) of 294 patients in the control group (difference 7·8%, 95% CI 2·5 to 13·1; p=0·0047; number needed to test=13). Mean length of stay was shorter in the POCT group (5·7 days [SD 6·3]) than in the control group (6·8 days [7·7]; difference −1·1, 95% CI −2·2 to −0·3; p=0·0443). Appropriate antiviral treatment of influenza-positive patients was more common in the POCT group (52 [91%] of 57 patients) than in the control group (24 [65%] of 37 patients; difference 26·4%, 95% CI 9·6 to 43·2; p=0·0026; number needed to test=4). We found no differences in adverse outcomes between the groups (77 [21%] of 360 patients in the POCT group vs 88 [25%] of 354 patients in the control group; −3·5%, −9·7 to 2·7; p=0·29). Routine use of molecular POCT for respiratory viruses did not reduce the proportion of patients treated with antibiotics. However, the primary outcome measure failed to capture differences in antibiotic use because many patients were started on antibiotics before the results of POCT could be made available. Although POCT was not associated with a reduction in the duration of antibiotics overall, more patients in the POCT group received single doses or brief courses of antibiotics than did patients in the control group. POCT was also associated with a reduced length of stay and improved influenza detection and antiviral use, and appeared to be safe. University of Southampton.