Shen XingRong, Diao MengJie, Lu ManMan, Feng Rui, Zhang PanPan, Jiang Tao, Wang DeBin
School of Health Services Management, Anhui Medical University, Hefei, Anhui, China.
Department of Literature Review and Analysis, Library of Anhui Medical University, Hefei, Anhui, China.
BMJ Open. 2018 Feb 20;8(2):e018519. doi: 10.1136/bmjopen-2017-018519.
Routine inpatient care (RIC) for patients with cancer forms various pathways of clinical procedures. Although most individual procedures comprising the pathways have been tested via clinical trials, little is known about the collective cost and effectiveness of the pathways as a whole. This study aims at exploring RIC pathways for patients with lung cancer from rural Anhui, China, and their determinants and economic impacts.
The study adopts a retrospective cohort design and proceeds in five steps. Step 1 defines the four main categories of study variables, including clinical procedures, direct cost and effectiveness of procedures, and factors affecting use of these procedures and their cost and effectiveness. Step 2 selects a cohort of 5000 patients with lung cancer diagnosed between 1 July 2015 and 30 June 2016 from rural Anhui by clustered random sampling. Step 3 retrieves the records of all the inpatient care episodes due to lung cancer and extracts data about RIC procedures, proximate variables (eg, Karnofsky Performance Status, Lung Function Score) of patient outcomes and related factors (eg, stage of cancer, age, gender), by two independent clinician researchers using a web-based form. Step 4 estimates the direct cost of each of the RIC procedures using micro-costing and collects data about ultimate patient outcomes (survival and progression-free survival) through a follow-up survey of patients and/or their close relatives. Step 5 analyses the data collected and explores pathways of RIC procedures and their relations with patient outcomes, costs, cost:effect ratios, and a whole range of clinical and sociodemographic factors using multivariate regression and path models.
The study protocol has been approved by an authorised ethics committee of Anhui Medical University (reference number: 20170312). Findings from the study will be disseminated through conventional academic routes such as peer-reviewed publications and presentations at regional, national and international conferences.
ISRCTN25595562.
癌症患者的常规住院治疗（RIC）形成了各种临床程序路径。尽管构成这些路径的大多数单独程序已通过临床试验进行了测试，但对于整个路径的总体成本和有效性却知之甚少。本研究旨在探索中国安徽农村肺癌患者的RIC路径及其决定因素和经济影响。
本研究采用回顾性队列设计，分五个步骤进行。第一步定义研究变量的四个主要类别，包括临床程序、程序的直接成本和有效性，以及影响这些程序使用及其成本和有效性的因素。第二步通过整群随机抽样从安徽农村地区选取2015年7月1日至2016年6月30日期间诊断出的5000例肺癌患者队列。第三步由两名独立的临床医生研究人员使用基于网络的表格检索所有因肺癌住院治疗的记录，并提取有关RIC程序、患者预后相关变量（如卡氏功能状态、肺功能评分）以及相关因素（如癌症分期、年龄、性别）的数据。第四步使用微观成本核算方法估算每个RIC程序的直接成本，并通过对患者和/或其近亲的随访调查收集有关最终患者预后（生存和无进展生存期）的数据。第五步分析收集到的数据，并使用多元回归和路径模型探索RIC程序路径及其与患者预后、成本、成本效益比以及一系列临床和社会人口统计学因素之间的关系。
本研究方案已获得安徽医科大学授权伦理委员会的批准（参考编号：20170312）。研究结果将通过传统学术途径传播，如同行评审出版物以及在地区、国家和国际会议上的报告。
ISRCTN25595562。
