McSweeney L A, O'Hara J T, Rousseau N S, Stocken D D, Sullivan F, Vale L, Wilkes S, Wilson J A, Haighton C A
Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.
ENT Department, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
Clin Otolaryngol. 2017 Jun;42(3):578-583. doi: 10.1111/coa.12781. Epub 2016 Nov 10.
Level one evidence on the value of adult tonsillectomy versus non-surgical management remains scarce. Before embarking on a costly national randomised controlled trial, it is essential to establish its feasibility.
Feasibility study with in-depth qualitative and cognitive interviews.
ENT staff and patients were recruited from nine hospital centres across England and Scotland.
Patients who were referred for tonsillectomy (n = 15), a convenience sample of general practitioners (n = 11) and ear, nose and throat staff (n = 22).
To ascertain whether ear, nose and throat staff would be willing to randomise patients to the treatment arms. To assess general practitioners' willingness to refer patients to the NAtional Trial of Tonsillectomy IN Adults (NATTINA) centres. To assess patients' willingness to be randomised and the acceptability of the deferred surgery treatment arm. To ascertain whether the study could progress to the pilot trial stage.
Ear, nose and throat staff and general practitioners were willing to randomise patients to the proposed NATTINA. Not all ENT staff were in equipoise concerning the treatment pathways. Patients were reluctant to be randomised into the deferred surgery group if they had already waited a substantial time before being referred.
Findings suggest that the NATTINA may not be feasible. Proposed methods could not be realistically assessed without a pilot trial. Due to the importance of the question, as evidenced by NATTINA clinicians, and strong support from ENT staff, the pilot trial proceeded, with modifications.
关于成人扁桃体切除术与非手术治疗价值的一级证据仍然稀缺。在开展一项成本高昂的全国随机对照试验之前,确定其可行性至关重要。
采用深入定性和认知访谈的可行性研究。
从英格兰和苏格兰的9个医院中心招募耳鼻喉科工作人员和患者。
被转诊进行扁桃体切除术的患者(n = 15)、全科医生的便利样本(n = 11)以及耳鼻喉科工作人员(n = 22)。
确定耳鼻喉科工作人员是否愿意将患者随机分配至各治疗组。评估全科医生将患者转诊至成人扁桃体切除术全国试验(NATTINA)中心的意愿。评估患者被随机分组的意愿以及延迟手术治疗组的可接受性。确定该研究是否能够推进至试点试验阶段。
耳鼻喉科工作人员和全科医生愿意将患者随机分配至拟议中的NATTINA试验组。并非所有耳鼻喉科工作人员在治疗途径方面都持中立态度。如果患者在被转诊之前已经等待了很长时间,他们不愿意被随机分配至延迟手术组。
研究结果表明NATTINA试验可能不可行。在没有试点试验的情况下,无法实际评估所提议方法是否可行。鉴于NATTINA临床医生所证明的该问题的重要性以及耳鼻喉科工作人员的大力支持进行了修改后,试点试验得以继续开展。