Quality of patient-reported outcome data captured using paper and interactive voice response diaries in an allergic rhinitis study: is electronic data capture really better?
Quality of patient-reported outcome data captured using paper and interactive voice response diaries in an allergic rhinitis study: is electronic data capture really better?
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DOI：
10.1016/s1081-1206(10)61571-2
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发表时间：
2004-03-01
影响因子：
5.9
通讯作者：
Weiler, JM
中科院分区：
文献类型：
--
作者：
Weiler, K;Christ, AM;Weiler, JM
背景资料：在变应性鼻炎试验中，日记数据的准确性和可靠性取决于受试者记录信息的方式和时间。目的：比较两种日记数据收集方法（光学标记可读）和电子[电话、交互式语音应答系统（IVRS）]工具。有一个随机，3周，3向，交叉试验，在87名成人过敏性鼻炎记录日记数据在家里。结果的措施是（1）比较的症状数据在几周内，当两个或只有我的仪器被使用;（2）缺失的数据;（3）易用性和参与者preference.Results：超过40,000症状数据元素被记录72个协议正确的主题。在使用两种器械的一周内和单独使用两种器械时记录的症状无法区分。总体而言，0.45%的论文和4.12%的IVRS症状数据缺失。在受试者同时使用纸质和IVRS日记的一周内，收集了10，080对数据，其中94.44%相同。使用IVRS，63.2%的协议正确的数据在指定的时间内输入，87.6%在规定的时间内半天; 85%的受试者首选纸质仪器，4%的首选IVRS，11%没有preference.Conclusions：一个基于纸张的仪器可以捕获数据从电子产品捕获的数据难以区分。应针对每项研究评估收集日记数据的过程，而不是简单地使用“最新”技术。另一种解释是记录日记数据的频率对结果没有显著影响。
Background: Accuracy and reliability of diary data collected in allergic rhinitis trials depends on how and when the information is recorded by the subjects.Objective: To compare diary data collected by using paper (optical mark readable) and electronic [telephone, interactive voice response system (IVRS)] tools.Methods: There was a randomized, 3-week, 3-way, crossover trial, in 87 adults with allergic rhinitis recording diary data at home. Outcome measures were (1) comparison of symptom data during weeks when both or only I instrument was used; (2) missing data; and (3) ease of use and participant preference.Results: More than 40,000 symptom data elements were recorded by 72 protocol-correct subjects. Symptoms recorded during the week that both instruments were used and when the 2 instruments were used alone were indistinguishable. Overall, 0.45% of paper and 4.12% of IVRS symptom data were missing. Of 10,080 paired data collected on paper and IVRS diaries during the week in which subjects used both, 94.44% were identical. Using IVRS, 63.2% of protocol-correct data were entered within the designated time and 87.6% within I half-day of the time specified; 85% of subjects preferred the paper instrument, 4% preferred IVRS, and 11% had no preference.Conclusions: A paper-based instrument can capture data indistinguishable from data captured from an electronic product. Processes to collect diary data should be evaluated for each study rather than simply to use the "latest" technology. Another interpretation is that frequency of recording diary data does not have a significant impact on outcomes.