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A feasibility study examining the effect on lung cancer diagnosis of offering a chest X-ray to higher-risk patients with chest symptoms: protocol for a randomized controlled trial

机译:一项可行性研究,研究为具有较高胸部症状​​的高危患者提供胸部X光检查对肺癌诊断的影响:一项随机对照试验的方案

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Background In order to improve lung cancer survival in the UK, a greater proportion of resectable cancers must be diagnosed. It is likely that resectability rates would be increased by more timely diagnosis. Aside from screening, the only way of achieving this is to reduce the time to diagnosis in symptomatic cancers. Currently, lung cancers are mainly diagnosed by general practitioners (GPs) using the National Institute for Health and Clinical Excellence (NICE) guidelines for urgent referral for chest X-ray, which recommend urgent imaging or referral for patients who have one of a number of chest symptoms for more than 3?weeks. We are proposing to expand this recommendation to include one of a number of chest symptoms of any duration in higher-risk patients. Methods/Design We intend to conduct a trial of imaging in these higher-risk patients and compare it with NICE guidelines to see if imaging improves stage at diagnosis and resection rates. This trial would have to be large (and consequently resource-intensive) because most of these patients will not have lung cancer, making optimal design crucial. We are therefore conducting a pilot trial that will ascertain the feasibility of running a full trial and provide key information that will be required in order to design the full trial. Discussion This trial will assess the feasibility and inform the design of a large, UK-wide, clinical trial of a change to the NICE guidelines for urgent referral for chest X-ray for suspected lung cancer. It utilizes a combination of workshop, health economic, quality of life, qualitative, and quantitative methods in order to fully assess feasibility. Trial registration Clinicaltrials.gov NCT01344005
机译:背景技术为了提高英国的肺癌生存率,必须诊断出较大比例的可切除癌症。通过更及时的诊断,可切除率可能会增加。除了筛查之外,实现此目的的唯一方法是减少有症状癌症的诊断时间。目前,肺癌主要由全科医生(GPs)使用美国国立卫生研究院(NICE)紧急转诊胸部X线指南进行诊断,该指南建议对具有以下多种疾病之一的患者进行紧急影像检查或转诊。胸部症状超过3周。我们提议将这一建议扩展为包括高危患者中任何持续时间的多种胸部症状之一。方法/设计我们打算在这些高危患者中进行影像学试验,并将其与NICE指南进行比较,以查看影像学在诊断和切除率方面是否可以改善分期。该试验必须庞大(因此需要大量资源),因为这些患者大多数不会患肺癌,因此优化设计至关重要。因此,我们正在进行一项试验性试验,以确定进行完整试验的可行性,并提供设计完整试验所需的关键信息。讨论该试验将评估可行性,并将为整个英国范围内的大型临床试验的设计提供信息,以更改NICE指南以紧急转诊可疑肺癌的胸部X线。它综合了车间,健康经济,生活质量,定性和定量方法,以全面评估可行性。试用注册Clinicaltrials.gov NCT01344005

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