Managing data for a randomised controlled clinical trial: experience from the WHO Antenatal Care Trial
Managing data for a randomised controlled clinical trial: experience from the WHO Antenatal Care Trial
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DOI：
10.1046/j.1365-3016.12.s2.2.x
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发表时间：
1998-10-01
影响因子：
2.8
通讯作者：
Gandeh, M
中科院分区：
文献类型：
--
作者：
Pinol, A;Bergel, E;Gandeh, M
世界卫生组织与四个发展中国家合作，正在进行一项随机对照临床试验，以评估一项新的产前保健计划。在阿根廷、古巴、沙特阿拉伯和泰国的一个城市或地区，随机分配53个临床单位提供新方案或目前使用的方案。本文介绍了数据管理系统的组织结构。用于对数据进行单元化。每位参加试验的妇女都有唯一的身份标识，她的姓名、地址和预产期等信息都记录在试验“受试者编号列表”中。如果诊所属于干预组，有关妇女资格的信息记录在分类表上。妊娠结果的详细情况在另外两份病例报告表上显示：产前住院表和摘要表。调查人员填好表格后，将表格提交国家数据协调中心。疾控中心负责处理国别学习表格。这包括批表格的验证，数据捕获到计算机文件中，数据验证数据验证，数据问题查询表的制作，研究主文件的维护和更新。对数据的所有操作，如添加或修改，都使用事务处理来执行。每隔一个月就向日内瓦的审判协调中心送交征聘报告和交易档案。所有事务文件都经过处理，以便在审判的合并主文件中积累数据。编写一份月度报告，包括在试验中招募的妇女人数、各国报告的不良事件、诊所招募图表以及对干预组中符合条件的妇女的分析，并提交给数据安全和监测委员会。1995年，在试验开始之前，组织了一次讲习班，向四个参与国介绍数据管理系统。每年实地视察各中心，以监察进度。当发展协调会无法解决重大或关键问题时，会进行额外的访问。在数据收集工作结束时，我们会进行一次访问，以审查和评估所有数据管理程序，包括填写表格、保存登记册、电脑档案、查询表、修改数据。此外，还对数据进行最后的清理，并编制一份分析文件，以便纳入集中试验分析和具体国家分析。根据在这次试验中获得的经验，只有在参与试验的疾控中心已经掌握有能力和经验丰富的工作人员的情况下，才能提倡分散的数据管理模式。各国数据管理系统和标准作业程序的统一性也是有效管理数据收集阶段的一个关键问题。
The World Health Organisation, in collaboration with four developing countries, is conducting a randomised controlled clinical trial to evaluate a new programme of antenatal care. In a city or region in Argentina,Cuba, Saudi Arabia and Thailand, 53 clinical units were randomly allocated to provide either the new programme or the programme currently in use. This paper describes the organisation of the data management system. used to celled the data.Each woman participating in the trial is uniquely identified, and information such as her name, address and expected delivery date is recorded in the trial 'subject number list'. If the clinic belongs to the intervention group, information about the woman's eligibility is recorded on the classification form. Details of the outcome of the pregnancy are indicated on two additional case report forms: the antenatal hospital admission form and the summary form. When forms are completed by the investigators, they are submitted to the country data coordinating centre (CDCC).The CDCCs are responsible for the processing of the country study forms. This includes verification of the batch of forms, data capture into computer files, data verification data validation, production of query sheets for data problems, maintenance and updating of study master files. All operations on data such as additions or modifications are performed using transaction processing. At monthly intervals, recruitment reports and transaction files are sent to the trial coordinating centre in Geneva. All transaction files are processed to accumulate data on the trial's consolidated master files. A monthly report including number of women recruited in the trial, adverse events reported by the countries, recruitment charts by clinic and analyses on eligible women in the intervention group is prepared and submitted to the data safety and monitoring committee.A workshop was organised in 1995, before the start of the trial, to introduce the data management system to the four participating countries. Annual site visits were made to each CDCC to monitor progress. Additional visits were made when major or critical problems could not be solved by the CDCC. At the closure of: data collection, a visit is made to review and assess all data management procedures including form filling, maintenance of registers, computer files, query sheets, data modifications. In addition, final cleaning of the data is performed, and an analysis file is produced for inclusion in the centralised trial analyses and in the country-specific analyses.Based on the experience gained in this trial, the decentralised data management model can be advocated only if CDCCs that will be involved in the trial are already in glace with competent and experienced staff. Uniformity of the data management system and of standard operating procedures across countries is also a crucial issue for the effective management of the data collection phase.