Firmino-Machado João, Mendes Romeu, Moreira Amélia, Lunet Nuno
EPIUnit-Instituto de Saúde Pública, Universidade do Porto, Porto, Portugal.
Unidade de Saúde Pública, ACeS Porto Ocidental, Porto, Portugal.
BMJ Open. 2017 Oct 5;7(10):e017730. doi: 10.1136/bmjopen-2017-017730.
Screening is highly effective for cervical cancer prevention and control. Population-based screening programmes are widely implemented in high-income countries, although adherence is often low. In Portugal, just over half of the women adhere to cervical cancer screening, contributing for greater mortality rates than in other European countries. The most effective adherence raising strategies are based on patient reminders, small/mass media and face-to-face educational programmes, but sequential interventions targeting the general population have seldom been evaluated. The aim of this study is to assess the effectiveness of a stepwise approach, with increasing complexity and cost, to improve adherence to organised cervical cancer screening: step 1a-customised text message invitation; step 1b-customised automated phone call invitation; step 2-secretary phone call; step 3-family health professional phone call and face-to-face appointment.
A population-based randomised controlled trial will be implemented in Portuguese urban and rural areas. Women eligible for cervical cancer screening will be randomised (1:1) to intervention and control. In the intervention group, women will be invited for screening through text messages, automated phone calls, manual phone calls and health professional appointments, to be applied sequentially to participants remaining non-adherent after each step. Control will be the standard of care (written letter). The primary outcome is the proportion of women adherent to screening after step 1 or sequences of steps from 1 to 3. The secondary outcomes are: proportion of women screened after each step (1a, 2 and 3); proportion of text messages/phone calls delivered; proportion of women previously screened in a private health institution who change to organised screening. The intervention and control groups will be compared based on intention-to-treat and per-protocol analyses.
The study was approved by the Ethics Committee of the Northern Health Region Administration and National Data Protection Committee. Results will be disseminated through communications in scientific meetings and peer-reviewed journals.
NCT03122275.
筛查对宫颈癌的预防和控制非常有效。基于人群的筛查项目在高收入国家广泛实施，尽管依从性往往较低。在葡萄牙，只有略多于一半的女性坚持进行宫颈癌筛查，这导致其死亡率高于其他欧洲国家。提高依从性最有效的策略基于患者提醒、小型/大众媒体以及面对面教育项目，但针对普通人群的序贯干预很少得到评估。本研究的目的是评估一种逐步推进的方法（复杂性和成本逐步增加）对提高参与有组织的宫颈癌筛查的依从性的有效性：第1a步——定制短信邀请；第1b步——定制自动电话邀请；第2步——秘书电话；第3步——家庭健康专业人员电话及面对面预约。
将在葡萄牙城乡地区开展一项基于人群的随机对照试验。符合宫颈癌筛查条件的女性将被随机（1:1）分为干预组和对照组。在干预组中，将通过短信、自动电话、人工电话和健康专业人员预约邀请女性进行筛查，这些措施将依次应用于每一步后仍未依从的参与者。对照组采用标准护理（书面信函）。主要结局是在第1步或第1至3步序列后依从筛查的女性比例。次要结局包括：每一步（1a、2和3）后接受筛查的女性比例；发送的短信/电话比例；之前在私立医疗机构接受过筛查的女性转而参加有组织筛查的比例。将基于意向性分析和符合方案分析对干预组和对照组进行比较。
本研究已获得北部卫生区域管理局伦理委员会和国家数据保护委员会的批准。研究结果将通过在科学会议上的交流以及同行评审期刊进行传播。
NCT03122275。
