McBride Emily, Marlow Laura, Forster Alice S, Moss Sue, Myles Jonathan, Kitchener Henry, Patnick Julietta, Waller Jo
Epidemiology and Public Health, Health Behaviour Research Centre, University College London, London, UK.
Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.
BMJ Open. 2016 Dec 23;6(12):e014356. doi: 10.1136/bmjopen-2016-014356.
The NHS Cervical Screening Programme is now using human papillomavirus (HPV) testing as the primary test in six sentinel sites in England, with the intention of rolling this out across the whole of England. Previous research evaluating HPV testing in the cervical screening context suggests that an HPV-positive result may increase anxiety beyond that associated with abnormal cytology, but this has not been explored in the context of primary HPV testing. The main aim of this study is to explore the impact of the HPV primary screening programme on anxiety and distress.
A cross-sectional between-groups design (total N ∼ 673) will be employed to assess the psychological impact of different HPV and cytology results at three time points: shortly after receiving the results, and 6 and 12 months later. Women will fall into one of six groups based on their screening results. The primary outcomes will be anxiety and general distress. Secondary outcomes will include understanding of screening results, perceived risk of cervical cancer, psychosexual functioning, intention to attend future screening and knowledge of HPV. General linear modelling will be used to test for differences between groups and changes over the three time points.
Health Research Authority approval was received on 26 September 2016. Ethical approval was received from London- Surrey Borders NHS Research Ethics Committee on 30 August 2016. Section 251 approval was received from the Confidentiality Advisory Group on 24 August 2016. Results will be disseminated via peer-reviewed publication and presentation at national and international conferences.
英国国家医疗服务体系（NHS）宫颈筛查项目目前正在英格兰的六个哨点地区将人乳头瘤病毒（HPV）检测作为主要检测方法，并打算在全英格兰推广。先前在宫颈筛查背景下评估HPV检测的研究表明，HPV阳性结果可能会增加焦虑程度，超过与细胞学异常相关的焦虑，但在HPV初筛的背景下尚未对此进行探讨。本研究的主要目的是探讨HPV初筛项目对焦虑和痛苦的影响。
将采用横断面组间设计（总样本量约673），在三个时间点评估不同HPV和细胞学结果的心理影响：收到结果后不久、6个月后和12个月后。根据筛查结果，女性将分为六组之一。主要结局指标将是焦虑和一般痛苦。次要结局指标将包括对筛查结果的理解、宫颈癌的感知风险、性心理功能、参加未来筛查的意愿以及对HPV的了解。将使用一般线性模型来检验组间差异以及三个时间点的变化情况。
2016年9月26日获得了健康研究管理局的批准。2016年8月30日获得了伦敦-萨里边境NHS研究伦理委员会的伦理批准。2016年8月24日获得了保密咨询小组的第251条批准。研究结果将通过同行评审发表以及在国内和国际会议上进行展示的方式进行传播。
