一项关于加拿大对低风险乳头状甲状腺癌进行主动监测或手术决策的前瞻性观察性研究方案。
A protocol for a Canadian prospective observational study of decision-making on active surveillance or surgery for low-risk papillary thyroid cancer.
作者信息
Sawka Anna M, Ghai Sangeet, Tomlinson George, Rotstein Lorne, Gilbert Ralph, Gullane Patrick, Pasternak Jesse, Brown Dale, de Almeida John, Irish Jonathan, Chepeha Douglas, Higgins Kevin, Monteiro Eric, Jones Jennifer M, Gafni Amiram, Goldstein David P
机构信息
Department of Endocrinology, University Health Network, University of Toronto, Toronto, Ontario, Canada.
Department of Radiology, University Health Network, University of Toronto, Toronto, Ontario, Canada.
出版信息
BMJ Open. 2018 Apr 12;8(4):e020298. doi: 10.1136/bmjopen-2017-020298.
INTRODUCTION
Low-risk papillary thyroid cancer (PTC) is increasingly being diagnosed throughout the world; yet the mortality risk is low compared with other malignancies. Traditional management includes thyroid surgery, sometimes followed by radioactive iodine and thyroid hormone treatment. Active surveillance (AS) has been proposed as a means to reduce overtreatment of PTC. AS involves close disease follow-up, with the intention to intervene if the disease progresses, or on patient request.
METHODS AND ANALYSIS
This is a multiphase prospective observational study. In the first phase of this study, consenting eligible adults with low-risk PTC, that is, <2 cm in maximal diameter, confined to the thyroid and not immediately adjacent to critical structures in the neck, are provided verbal and written information about PTC disease prognosis following surgery or AS. Questionnaires are administered at baseline and after the disease management decision on AS or surgery is finalised. Patients may choose either option (surgery or AS), and the primary outcome is the frequency with which either disease management option is chosen. Secondary outcomes include: rationale for the decision, role of the patient in decision-making and decision satisfaction. In the second phase of the study, consenting eligible adult patients who completed the first study phase may enrol in respective AS or surgery group follow-up studies. The following outcomes are examined 1 year after enrolment in the follow-up phase: decision regret about disease management choice (primary outcome), psychological distress, disease-specific quality of life, fear of disease progression, body image satisfaction, disease progression, crossover to surgery in the AS group, new chronic thyroid hormone use and healthcare resource utilisation.
ETHICS AND DISSEMINATION
The University Health Network Research Ethics Board approved this study (ID 15-8942). The results will be published in an open access journal.
TRIAL REGISTRATION NUMBER
NCT03271892; Pre-results.
引言
低风险甲状腺乳头状癌（PTC）在全球的诊断率日益增加；然而，与其他恶性肿瘤相比，其死亡风险较低。传统治疗方法包括甲状腺手术，有时术后还会进行放射性碘和甲状腺激素治疗。主动监测（AS）已被提议作为减少PTC过度治疗的一种手段。主动监测包括密切的病情随访，目的是在疾病进展时或应患者要求进行干预。
方法与分析
这是一项多阶段前瞻性观察性研究。在本研究的第一阶段，向符合条件且同意参与的低风险PTC成年患者（即最大直径<2厘米、局限于甲状腺且不紧邻颈部关键结构）提供有关手术或主动监测后PTC疾病预后的口头和书面信息。在基线以及确定主动监测或手术的疾病管理决策后进行问卷调查。患者可以选择任何一种方案（手术或主动监测），主要结局是选择任何一种疾病管理方案的频率。次要结局包括：决策理由、患者在决策过程中的作用以及决策满意度。在研究的第二阶段，完成第一研究阶段且符合条件并同意参与的成年患者可以参加各自的主动监测或手术组的随访研究。在进入随访阶段1年后检查以下结局：对疾病管理选择的决策遗憾（主要结局）、心理困扰、疾病特异性生活质量、对疾病进展的恐惧、身体形象满意度、疾病进展、主动监测组转为手术治疗、新的慢性甲状腺激素使用情况以及医疗资源利用情况。
伦理与传播
大学健康网络研究伦理委员会批准了本研究（编号15 - 8942）。研究结果将发表在开放获取期刊上。
试验注册号
NCT03271892；预结果。
Zotero 插件