• 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Controlled clinical trials >Symptom recording in a randomised clinical trial: paper diaries vs. electronic or telephone data capture.
【24h】

Symptom recording in a randomised clinical trial: paper diaries vs. electronic or telephone data capture.

机译：随机临床试验中的症状记录：纸质日记与电子或电话数据捕获。

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

BACKGROUND: Patients may be asked to register a symptom daily in clinical trials. A problem associated with this kind of registration is that patients do not always fill in the diary at the appropriate time. As there is evidence showing that memory is unreliable, this undermines the entire purpose of collecting daily data on paper diaries. We aimed to compare accuracy, autocorrelations of consecutive entries, and responsiveness in paper diaries (P-Diaries) with electronic diaries (E-Diaries) and telephone diaries (T-Diaries). METHODS: In a multi-centre, open, and parallel trial, 177 patients were allocated at random to P-Diaries, E-Diaries, or T-Diaries for the registration of symptoms through 4 weeks of treatment of gastro-oesophageal reflux disease (GORD). The primary outcome measure was the diaries. FINDINGS: The proportion of patients completing all morning and all evening entries on time was low for both E-Diary and T-Diary groups. By accepting entries that were done half a day late, the proportion was increased to 19/57 (33%) for the E-Diary group, and to 9/61 (15%) for the T-Diary group. For P-Diary, where no control for time registration and entries was adapted, 37/59 (63%) of the patients completed all morning and all evening entries. A significant higher autocorrelation in P-Diaries was also found. Responsiveness was similar regardless of method of data capture. INTERPRETATION: The results are consistent with the suggestion that data in the P-Diaries are not filled in at the appropriate time. Use of E-Diaries or T-Diaries improves quality and is recommended in future clinical trials.
机译：背景：在临床试验中可能会每天要求患者记录症状。与这种注册相关的问题是，患者并不总是在适当的时间填写日记。由于有证据表明记忆不可靠，因此破坏了在纸质日记中收集日常数据的整个目的。我们旨在比较纸质日记本（P-Diaries），电子日记本（E-Diaries）和电话日记本（T-Diaries）的准确性，连续条目的自相关性和响应性。方法：在一项多中心，开放且平行的试验中，通过治疗胃食管反流病4周，将177名患者随机分配至P日记，E日记或T日记以记录症状（上帝）。主要结果指标是日记。结果：E-日记和T-日记组的患者在整个上午和晚上按时完成输入的比例很低。通过接受半天之后提交的条目，E-Diary组的比例增加到19/57（33％），而T-Diary组的比例增加到9/61（15％）。对于P-Diary，由于没有调整时间注册和入场控制，因此37/59（63％）的患者在整个上午和晚上都完成了输入。还发现P日记中的自相关显着较高。不管数据捕获方法如何，响应性都是相似的。解释：结果与以下建议相符：P日记中的数据未在适当的时间填写。使用电子日记或T日记可以提高质量，并建议在以后的临床试验中使用。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号