Observational study of the development and evaluation of a fertility preservation patient decision aid for teenage and adult women diagnosed with cancer: the Cancer, Fertility and Me research protocol
Observational study of the development and evaluation of a fertility preservation patient decision aid for teenage and adult women diagnosed with cancer: the Cancer, Fertility and Me research protocol
复制标题
DOI：
10.1136/bmjopen-2016-013219
复制
发表时间：
2017-03-01
期刊：
影响因子：
2.9
通讯作者：
Bekker, H. L.
中科院分区：
文献类型：
--
作者：
Jones, G. L.;Hughes, J.;Bekker, H. L.
简介：被诊断患有癌症并面临可能绝育的癌症治疗的妇女在接受肿瘤学服务治疗癌症的同时，不得不在时间紧迫的情况下做出关于通过专业生育服务保持生育能力的决定。肿瘤学家确定需要资源，使他们能够更有效地支持妇女的生育能力保存的决定;妇女报告说，希望更多的专业信息，使这些决定。“癌症、生育力和我”研究的总体目标是为考虑保留生育力的任何癌症女性开发和评估一种新的循证患者决策辅助工具（PtDA），以解决这一未满足的需求。方法和分析：这是一项包括育龄妇女的前瞻性混合方法观察性研究（16岁以上）在英国约克郡的两个区域癌症和生育中心新诊断出任何癌症。研究分为三个阶段。在第1阶段，目的是使用系统的证据合成方法和对当前临床实践和患者信息的多学科专家审查来开发PtDA。在第二阶段，目的是评估PtDA的表面效度。将通过问卷调查和与患者、用户群体和主要利益相关者的访谈，确定对该报告内容和格式的反馈。最后，在第3阶段，将评估在癌症诊断和治疗计划时将此资源整合到常规癌症护理途径中的可接受性。这将涉及PtDA在临床实践中的定量和定性评价。选择的措施包括使用计数数据的PtDA在诊所管理和在线访问，决策和患者报告的结果措施和定性反馈。将使用描述性统计、配对样本t检验和CI对定量数据进行分析;将使用主题分析对访谈进行分析。伦理和传播：已授予研究伦理委员会批准（参考：16/EM/0122）和健康研究管理局批准（参考：194751）。研究结果将发表在开放获取的同行评审期刊上，在学术和卫生专业人士会议上发表，并向卫生专业人员和项目经理提供反馈。癌症，生育和我患者决策援助（PtDA）将通过各种开放访问媒体，研究和慈善网站，专业组织和学术来源进行传播。将寻求国际患者决策辅助标准（IPDAS）协作PtDA和其他相关专业组织（例如英国生育学会）的外部认可。
Introduction: Women diagnosed with cancer and facing potentially sterilising cancer treatment have to make time-pressured decisions regarding fertility preservation with specialist fertility services while undergoing treatment of their cancer with oncology services. Oncologists identify a need for resources enabling them to support women's fertility preservation decisions more effectively; women report wanting more specialist information to make these decisions. The overall aim of the 'Cancer, Fertility and Me' study is to develop and evaluate a new evidence-based patient decision aid (PtDA) for women with any cancer considering fertility preservation to address this unmet need.Methods and analysis: This is a prospective mixedmethod observational study including women of reproductive age (16 years +) with a new diagnosis of any cancer across two regional cancer and fertility centres in Yorkshire, UK. The research involves three stages. In stage 1, the aim is to develop the PtDA using a systematic method of evidence synthesis and multidisciplinary expert review of current clinical practice and patient information. In stage 2, the aim is to assess the face validity of the PtDA. Feedback on its content and format will be ascertained using questionnaires and interviews with patients, user groups and key stakeholders. Finally, in stage 3 the acceptability of using this resource when integrated into usual cancer care pathways at the point of cancer diagnosis and treatment planning will be evaluated. This will involve a quantitative and qualitative evaluation of the PtDA in clinical practice. Measures chosen include using count data of the PtDAs administered in clinics and accessed online, decisional and patient-reported outcome measures and qualitative feedback. Quantitative data will be analysed using descriptive statistics, paired sample t-tests and CIs; interviews will be analysed using thematic analysis.Ethics and dissemination: Research Ethics Committee approval (Ref: 16/EM/0122) and Health Research Authority approval (Ref: 194751) has been granted. Findings will be published in open access peer-reviewed journals, presented at conferences for academic and health professional audiences, with feedback to health professionals and program managers. The Cancer, Fertility and Me patient decision aid (PtDA) will be disseminated via a diverse range of open-access media, study and charity websites, professional organisations and academic sources. External endorsement will be sought from the International Patient Decision Aid Standards (IPDAS) Collaboration inventory of PtDAs and other relevant professional organisations, for example, the British Fertility Society.